FDA 510(k) Applications for Medical Device Product Code "LFL"
(Instrument, Ultrasonic Surgical)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K101561 | AMERICAN OPTISURGICAL, INC. | TX1 TISSUE REMOVAL SYSTEM | 08/27/2010 |
| K031523 | AOMORI OLYMPUS CO., LTD. | OLYMPUS ULTRASONIC SURGICAL SYSTEM | 10/01/2003 |
| K031710 | AOMORI OLYMPUS CO., LTD. | OLYMPUS ULTRASONIC SURGICAL SYSTEM | 08/29/2003 |
| K042160 | AOMORI OLYMPUS CO., LTD. | SONOSURG TROCAR | 01/25/2005 |
| K041566 | AOMORI OLYMPUS CO., LTD. | SONOSURG ULTRASONIC SURGICAL SYSTEM | 09/08/2004 |
| K062544 | AROBELLA MEDICAL, LLC | AR1000 ULTRASONIC WOUND THERAPY SYSTEM | 01/03/2007 |
| K021929 | AXYA MEDICAL, INC. | AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM | 09/10/2002 |
| K964742 | AZIZ Y. ANIS, M.D. | RONIX II ROTARY ULTRASONIC SURGICAL SYSTEM | 04/22/1997 |
| K980895 | CALIFORNIA INSTITUTE OF TISSUE ENG. & INSTRUMENTI | ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR | 11/06/1998 |
| K153371 | COVIDIEN LLC | Sonicision Cordless Ultrasonic Dissection Device | 03/28/2016 |
| K101797 | COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO | SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T | 02/24/2011 |
| K141371 | COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H | SONICISION CORDLESS ULTRASONIC DISSECTOR | 08/07/2014 |
| K212301 | Covidien, LLC | Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device | 11/15/2021 |
| K200427 | Covidien, llc | Sonicision Cordless Ultrasonic Dissector | 07/10/2020 |
| K180149 | Covidien, llc | Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide | 03/26/2018 |
| K150271 | ENDOPRIME, INC. | Prime Adaptive Ultrasonic Scalpel System | 05/29/2015 |
| K160752 | ETHICON ENDO-SUREGERY, LLC | HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length | 06/29/2016 |
| K042777 | ETHICON ENDO-SURGERY, INC. | HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P | 12/01/2004 |
| K051036 | ETHICON ENDO-SURGERY, INC. | HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P | 06/02/2005 |
| K053056 | ETHICON ENDO-SURGERY, INC. | HARMONIC SCALPEL BLADES AND SHEARS | 01/19/2006 |
| K060245 | ETHICON ENDO-SURGERY, INC. | HARMONIC SCALPEL BLADES AND SHEARS | 04/07/2006 |
| K062000 | ETHICON ENDO-SURGERY, INC. | HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH | 09/25/2006 |
| K980099 | ETHICON ENDO-SURGERY, INC. | ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5)) | 04/09/1998 |
| K962584 | ETHICON ENDO-SURGERY, INC. | ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE | 11/04/1996 |
| K983316 | ETHICON ENDO-SURGERY, INC. | ULTRACISION 5MM INSTRUMENTS | 10/21/1998 |
| K971302 | ETHICON ENDO-SURGERY, INC. | ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADE | 07/07/1997 |
| K012176 | ETHICON ENDO-SURGERY, INC. | ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145 | 10/01/2001 |
| K010898 | ETHICON ENDO-SURGERY, INC. | ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145 | 05/31/2001 |
| K993054 | ETHICON ENDO-SURGERY, INC. | ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141 | 12/09/1999 |
| K990430 | ETHICON ENDO-SURGERY, INC. | ULTRACISION HARMONIC SCALPEL HAND PIECE | 03/12/1999 |
| K994280 | ETHICON ENDO-SURGERY, INC. | ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105 | 03/17/2000 |
| K002906 | ETHICON ENDO-SURGERY, INC. | ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07 | 12/15/2000 |
| K072203 | ETHICON ENDO-SURGERY, LLC | HARMONIC 10CM COMBINATION HOOK BLADE | 09/25/2007 |
| K221790 | Ethicon Endo-Surgery, LLC | HARMONIC 700 Shears | 02/28/2023 |
| K132522 | ETHICON ENDO-SURGERY, LLC | HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE | 12/16/2013 |
| K132512 | ETHICON ENDO-SURGERY, LLC | HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE | 10/24/2013 |
| K121550 | ETHICON ENDO-SURGERY, LLC | HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY | 08/22/2012 |
| K132612 | ETHICON ENDO-SURGERY, LLC | HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE | 10/17/2013 |
| K063192 | ETHICON ENDO-SURGERY, LLC | HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP | 01/30/2007 |
| K151340 | ETHICON ENDO-SURGERY, LLC | HARMONIC Focus Long Shears + Adaptive Tissue Technology | 07/10/2015 |
| K100597 | ETHICON ENDO-SURGERY, LLC | HARMONIC FOCUS SHEARS | 04/07/2010 |
| K133314 | ETHICON ENDO-SURGERY, LLC | HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY | 12/03/2013 |
| K211273 | Ethicon Endo-Surgery, LLC | Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray | 05/21/2021 |
| K191555 | Ethicon Endo-Surgery, LLC | HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length | 02/28/2020 |
| K151136 | ETHICON ENDO-SURGERY, LLC | HARMONIC HOOK | 03/04/2016 |
| K120729 | ETHICON ENDO-SURGERY, LLC | HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23 | 05/17/2012 |
| K983199 | FIBRA SONICS, INC. | FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL | 12/14/1998 |
| K980930 | FIBRA SONICS, INC. | FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA | 09/22/1998 |
| K113570 | INTEGRA BURLINGTON MA, INC. | INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP | 02/22/2012 |
| K111741 | INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI | INTEGRA(TM) CUSA NXT(TM) BONE TIPS | 08/23/2011 |
| K150682 | INTEGRA LIFESCIENCES CORP. | CUSA Excel+ | 12/18/2015 |
| K200774 | Integra LifeSciences Corporation | CUSA Clarity Ultrasonic Surgical Aspirator System | 06/23/2020 |
| K221763 | Integra LifeSciences Corporation | CUSA Clarity Ultrasonic Surgical Aspirator System | 07/15/2022 |
| K230427 | Integra Lifesciences Corporation | CUSA Clarity Ultrasonic Surgical Aspirator System | 07/11/2023 |
| K221835 | Integra Lifesciences Corporation | CUSA Clarity Ultrasonic Surgical Aspirator System | 08/22/2022 |
| K161882 | INTEGRA LIFESCIENCES CORPORATION | CUSA Clarity Ultrasonic Surgical Aspirator System | 10/14/2016 |
| K182809 | Integra LifeSciences Corporation | CUSA Clarity Ultrasonic Surgical Aspirator System | 12/07/2018 |
| K190180 | Integra LifeSciences Corporation | CUSA Clarity Ultrasonic Surgical Aspirator System | 04/01/2019 |
| K141668 | INTEGRA LIFESCIENCES CORPORATION | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM | 11/06/2014 |
| K141674 | INTEGRA LIFESCIENCES CORPORATION | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM | 11/06/2014 |
| K172595 | Integra LifeSciences Corporation | CUSA Excel+ Ultrasonic Surgical Aspirator System | 09/28/2017 |
| K021989 | INTEGRA NEUROSCIENCES | SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 | 09/13/2002 |
| K042277 | INTEGRA NEUROSCIENCES, LTD. | SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM | 09/29/2004 |
| K090864 | INTEGRA RADIONICS, INC. | CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM | 05/08/2009 |
| K102258 | INTEGRA RADIONICS, INC. | CUSA NXT EXTENDED LENGTH TIP | 06/10/2011 |
| K081459 | INTEGRA RADIONICS, INC. | CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM | 08/13/2008 |
| K071669 | INTEGRA RADIONICS, INC. | INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP | 08/17/2007 |
| K192963 | Katalyst Surgical, LLC | Kogent Torus Ultrasonic Aspirator | 06/19/2020 |
| K070360 | KIRWAN SURGICAL PRODUCTS, INC. | KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 | 08/07/2007 |
| K972148 | MEDICAMAT S.A. | B.U.S. ENDOTRON | 12/10/1997 |
| K190281 | MediSonic Technology Co | Ultrasonic Surgical System | 10/31/2019 |
| K970471 | MENTOR CORP. | MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS) | 07/17/1997 |
| K983065 | MENTOR CORP. | MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM | 12/01/1998 |
| K210567 | Miconvey Technologies Co., Ltd. | Ultrasonic Surgical System | 09/30/2022 |
| K212060 | Misonix Inc. | neXus Ultrasonic Surgical Aspirator System | 12/13/2021 |
| K221235 | Misonix Inc. | neXus Ultrasonic Surgical Aspirator System | 07/28/2022 |
| K000927 | MISONIX, INC. | ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4 | 10/10/2000 |
| K012028 | MISONIX, INC. | ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 | 07/27/2001 |
| K050776 | MISONIX, INC. | AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM | 06/06/2005 |
| K032690 | MISONIX, INC. | MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM | 12/09/2003 |
| K070313 | MISONIX, INC. | MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM | 05/11/2007 |
| K982841 | MISONIX, INC. | MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4 | 09/04/1998 |
| K190160 | Misonix, Inc. | neXus Ultrasonic Surgical Aspirator System | 05/30/2019 |
| K062471 | MISONIX, INC. | ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF | 10/26/2006 |
| K231117 | Misonix, LLC, a Bioventus Company | neXus Ultrasonic Surgical Aspirator System | 06/23/2023 |
| K962525 | MORWEL CORP. | ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM | 09/19/1996 |
| K010309 | MUTOH AMERICA CO., LTD. | SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR | 04/18/2001 |
| K172691 | OLYMPUS MEDICAL SYSTEMS CORP. | Ultrasonic Generator | 10/04/2017 |
| K050885 | OLYMPUS MEDICAL SYSTEMS CORPORATION | OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG | 06/03/2005 |
| K211838 | Olympus Medical Systems Corporation | Ultrasonic Bipolar Generator USG-410 with accessories | 08/04/2021 |
| K031305 | OLYMPUS OPTICAL CO., LTD. | OLYMPUS ULTRASONIC SURGICAL SYSTEM | 09/23/2003 |
| K993628 | OMNISONICS MEDICAL TECHNOLOGIES | OMNISONICS ULTRASONIC PROBES | 12/15/1999 |
| K003824 | OMNISONICS MEDICAL TECHNOLOGIES | OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI | 03/08/2001 |
| K051947 | RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP | RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE | 08/22/2005 |
| K971609 | SERVIZI MEDICO ESTETICI ITALINAI SRL. | SCULPTURE | 08/14/1997 |
| K960040 | SHARPLAN LASERS, INC. | SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE | 04/29/1996 |
| K202299 | SMTP Technology Co., Ltd | Ultrasonic Surgical Aspirator System | 05/21/2021 |
| K212750 | SMTP Technology Co., Ltd. | Ultrasonic Surgical Aspirator System, Model: XD880B | 09/27/2021 |
| K072904 | SOERING GMBH | SONOCA 180/195 WOUND CARE SYSTEM | 05/21/2008 |
| K971533 | SONICS & MATERIALS, INC. | VIBRA-SURGE SYSTEM MODEL VS2120 | 07/25/1997 |
| K990572 | SONOKINETICS, INC. | SONOTOME | 05/21/1999 |
| K012753 | SORING GMBH MEDIZINTECHNIK | SORING GMBH SONOCA 180/190 | 11/13/2001 |
| K991791 | SOUND SURGICAL TECHNOLOGIES LLC. | SOUND VASER SYSTEM | 08/12/1999 |
| K993868 | SOUND SURGICAL TECHNOLOGIES LLC. | THE SOUNDVASER DISSECTION SYSTEM | 12/21/1999 |
| K221102 | SRA Developments Ltd | LOTUS Series 4 Enhanced Shears, LOTUS Series 5 | 12/15/2022 |
| K032424 | SRA DEVELOPMENTS, LTD. | LOTUS | 12/16/2003 |
| K151101 | SRA DEVELOPMENTS, LTD. | Lotus Series 4 Ultrasonic Surgical System & Accessories | 07/17/2015 |
| K063531 | SRA DEVELOPMENTS, LTD. | SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM | 02/22/2007 |
| K223770 | Stryker Corporation | Sonopet 1Q 3 7cm 1Q Large | 02/16/2023 |
| K190070 | Stryker Corporation | Sonopet iQ Ultrasonic Aspirator System | 04/11/2019 |
| K213824 | Stryker Corporation | Sonopet iQ Ultrasonic Aspirator System | 02/03/2022 |
| K212614 | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Ultrasonic Scalpel System | 07/18/2022 |
| K010637 | SYNERGETICS, INC. | SONOTOME ULTRASONIC ASPIRATOR TIPS | 04/20/2001 |
| K020220 | SYNERGETICS, INC. | ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE | 08/23/2002 |
| K212049 | TendoNova Corporation | Oclet TDS 1000 | 03/08/2022 |
| K123640 | TENEX HEALTH | TX1 TISSUE REMOVAL SYSTEM | 03/20/2013 |
| K153299 | TENEX HEALTH, INC. | Tenex Health TX System | 03/03/2016 |
| K181367 | Tenex Health, Inc. | Tenex Health TX System with the TXP MicroTip | 08/28/2018 |
| K972114 | THE OLYMPUS OPTICAL CO. | OLYMPUS SONOSURG SYSTEM | 05/18/1998 |
| K000095 | THE OLYMPUS OPTICAL CO. | OLYMPUS SONOSURG TROCAR XT3900 SYSTEM | 09/26/2000 |
| K021962 | THE OLYMPUS OPTICAL CO. | OLYMPUS ULTRASONIC SURGICAL SYSTEM | 02/12/2003 |
| K032066 | THE OLYMPUS OPTICAL CO. | SONOSURG SYSTEM | 10/03/2003 |
| K960374 | ULTRALASE TECHNOLOGIES, INC. | ULTRACUT 2000 | 06/28/1996 |
| K971861 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC | ULTRASONIC HAND INSTRUMENTS | 07/01/1997 |
| K981262 | VALLEYLAB, INC. | CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM | 07/06/1998 |
| K964601 | VALLEYLAB, INC. | CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY | 01/16/1997 |
| K971580 | WELLS JOHNSON CO. | UAS ULTRASONIC ASPIRATOR SYSTEM | 12/09/1997 |
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