FDA 510(k) Applications for Medical Device Product Code "HET"
(Laparoscope, Gynecologic (And Accessories))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K190190 | 270Surgical Ltd | WV1 Endoscope | 11/01/2019 |
| K210104 | 270Surgical Ltd. | SurroundScope System | 07/08/2021 |
| K010510 | A & A MEDICAL, INC. | BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 | 05/16/2001 |
| K955412 | AMERICAN SURGICAL DEVICES | A.S.D. SAFETY TROCAR | 05/14/1996 |
| K962777 | APPLIED MEDICAL RESOURCES | AMR MINI-LAPAROSCOPE | 08/06/1997 |
| K963359 | APPLIED MEDICAL RESOURCES | INSUFFLATION NEEDLE | 09/24/1996 |
| K062169 | APPLIED MEDICAL RESOURCES CORP. | APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS | 08/24/2006 |
| K040295 | APPLIED MEDICAL RESOURCES CORP. | APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS | 03/12/2004 |
| K972647 | COOK UROLOGICAL, INC. | CO2 PNEUMO-DISSECTOR | 04/10/1998 |
| K960262 | COOK UROLOGICAL, INC. | CORING MORCELLATOR | 04/15/1996 |
| K021237 | COOPERSURGICAL, INC. | COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS | 04/10/2003 |
| K971837 | COOPERSURGICAL, INC. | VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820 | 08/06/1997 |
| K971836 | COOPERSURGICAL, INC. | VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR | 11/07/1997 |
| K000199 | CORTEK ENDOSCOPY, INC. | CORTEK MINI LAPAROSCOPE | 04/13/2000 |
| K980166 | CUDA PRODUCTS CO. | LIGHTSOURCE OR ILLUMINATOR | 04/01/1998 |
| K974763 | DEROYAL INDUSTRIES, INC. | DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA | 07/10/1998 |
| K990372 | DR. FRITZ GMBH | MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY | 10/14/1999 |
| K001220 | ETHICON ENDO-SURGERY, INC. | ENDOPATH SURESEAL REDUCER CAP | 05/16/2000 |
| K965045 | ETHICON ENDO-SURGERY, INC. | TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE | 05/05/1997 |
| K100280 | ETHICON, INC. | GYNCARE MORCELLEX TISSUE MORCELLATOR | 03/24/2010 |
| K993801 | ETHICON, INC. | GYNECARE LAPAROSCOPIC MORCELLATOR | 02/07/2000 |
| K061050 | ETHICON, INC. | GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R | 07/14/2006 |
| K131656 | ETHICON, INC. | MORCELLEX SIGMA GENERATOR | 09/27/2013 |
| K954774 | GABRIS SURGICAL CORP. | SHIELDED TROCAR (OBTURATOR) | 06/07/1996 |
| K003805 | GLOBAL ENDOSCOPY, INC. | GYNECOLOGICAL LAPAROSCOPES | 07/22/2001 |
| K970968 | GUENTER BISSINGER MEDIZINTECHNIK GMBH | BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS | 05/21/1998 |
| K020143 | GUIDANT CORPORATION, CARDIAC SURGERY | VASOVIEW 5 HARVESTING CANNULA | 02/20/2002 |
| K033177 | GUNTER BISSINGER MEDIZINTECHNIK GMBH | POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX | 03/11/2004 |
| K963872 | GYNECARE INNOVATION CENTER | FEMRX MORCELLATOR SYSTEM | 01/17/1997 |
| K954775 | GYNECARE INNOVATION CENTER | FLO-STAT FLUID MONITORING SYSTEM | 05/10/1996 |
| K962246 | HEALTH CARE INTERNATIONAL ASSOC. | RIGID FIBER OPTIC LAPAROSCOPE | 02/07/1997 |
| K942389 | HOGAN & HARTSON | TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES | 02/16/1996 |
| K971255 | IMAGYN MEDICAL, INC. | IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER | 04/21/1997 |
| K965055 | IMAGYN MEDICAL, INC. | IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES | 03/06/1997 |
| K982428 | INNERVISION, INC. | CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT) | 10/09/1998 |
| K050404 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS | 04/21/2005 |
| K022384 | ISOLUX AMERICA | XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP | 10/18/2002 |
| K972488 | KARL STORZ ENDOSCOPY | KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES | 01/22/1998 |
| K990004 | KARL STORZ ENDOSCOPY-AMERICA, INC. | DCI ENDOSCOPE | 04/02/1999 |
| K962090 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ MODEL 203210 O1 UNIMAT PLUS | 09/30/1996 |
| K950335 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY | 05/16/1996 |
| K951343 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES | 04/11/1996 |
| K962985 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES | 12/19/1997 |
| K981130 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA ENDO TIP SYSTEM | 08/19/1998 |
| K980694 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA PLASTIC TROCARS | 05/08/1998 |
| K964379 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA PUNCTURE CANNULA | 01/29/1997 |
| K963949 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA UNIMAT PLUS | 12/19/1996 |
| K963960 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA UNIMAT PLUS | 12/20/1996 |
| K973304 | KARL STORZ ENDOSCOPY-AMERICA, INC. | MVM 3.3 MM MICROENDOSCOPE | 12/02/1997 |
| K150525 | KARL STORZ ENDOSCOPY-AMERICA, INC. | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | 11/20/2015 |
| K970712 | L & T S.N.C. DI E. LUCINI & C. | LAPARO-TENSER | 07/21/1998 |
| K101458 | LINA MEDICAL APS | LINA XCISE MODEL MOR-1515 | 03/11/2011 |
| K971797 | LOUISVILLE LABORATORIES, INC. | LAPAROSCOPIC BLADDER NECK SUSPENSION KIT | 07/22/1997 |
| K963076 | LOUISVILLE LABORATORIES, INC. | LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY | 04/04/1997 |
| K960810 | MARLO SURGICAL TECHNOLOGY | BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM | 10/21/1996 |
| K022748 | MEDICAL DEVICE SERVICES | REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS | 10/09/2002 |
| K992480 | MEDIFIX, INC. | MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES | 09/23/1999 |
| K172796 | MEDROBOTICS CORPORATION | Flex Robotic System and Flex Transabdominal Drive | 01/18/2018 |
| K982276 | MICROPTIX INT'L, LLC. | BAHO AUTOCLAVABLE LAPAROSCOPE | 02/18/1999 |
| K043013 | MILTEX, INC. | MILTEX LAPAROSCOPIC INSTRUMENTS | 03/04/2005 |
| K971896 | NETOPTIX CORP. | GALILEO HIGH RESOLUTION MICRO COUPLER | 10/10/1997 |
| K080365 | NOUVAG AG | MORCE POWER PLUS AND VARIOCARVE MORCELLATOR | 06/29/2009 |
| K961860 | OLYMPUS AMERICA, INC. | A4907 LENS CLEANING SHEATH | 08/29/1996 |
| K111788 | OLYMPUS AMERICA, INC. | ENDOEYE HD II | 01/13/2012 |
| K955456 | OLYMPUS AMERICA, INC. | OES LAPARO-THORACO VIDEOSCOPE (RIGID) | 02/22/1996 |
| K955403 | OLYMPUS AMERICA, INC. | OES LAPARO-THORACO VIDEOSCOPE TYPE V | 03/11/1996 |
| K201832 | Olympus Medical Systems Corp. | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | 09/17/2021 |
| K123365 | OLYMPUS MEDICAL SYSTEMS CORP. | OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 | 03/01/2013 |
| K111425 | OLYMPUS MEDICAL SYSTEMS CORP. | OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 | 04/20/2012 |
| K151011 | Olympus Medical Systems Corp. | VISERA 4K UHD SYSTEM | 10/01/2015 |
| K081173 | OLYMPUS MEDICAL SYSTEMS CORPORATION | ENDOSCOPIC CO2 REGULATION UNIT UCR | 12/23/2008 |
| K080948 | OLYMPUS MEDICAL SYSTEMS CORPORATION | HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH | 09/26/2008 |
| K190744 | Olympus Winter & Ibe GmbH | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) | 08/29/2019 |
| K965121 | ORIGIN MEDSYSTEMS, INC. | CANNULA | 03/20/1997 |
| K960936 | ORIGIN MEDSYSTEMS, INC. | RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES] | 07/24/1996 |
| K062097 | PAJUNK GMBH MEDIZINTECHNOLOGIE | VERESS CANNULA AND MODULAR VERESS CANNULA | 10/13/2006 |
| K964450 | PILLING WECK GROUP | SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT | 01/10/1997 |
| K221642 | Precision Robotics (Hong Kong) Limited | SIRIUS Endoscope System | 12/12/2022 |
| K953360 | R-MED, INC. | R-MED ABDOMINAL WALL ELEVATOR | 01/11/1996 |
| K961922 | RANFAC CORP. | RDP-2 | 08/09/1996 |
| K003417 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET | 04/04/2001 |
| K973737 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M | 12/12/1997 |
| K960299 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE | 10/28/1996 |
| K970105 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS | 03/04/1997 |
| K003164 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM | 01/08/2001 |
| K041321 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM | 07/09/2004 |
| K201617 | Schoelly Fiberoptic GmbH | TipVision Videoscope System (TipVision VideoScope 0░/30░; EleVision HD 2 Camera Control Unit (CCU)) | 03/12/2021 |
| K200216 | Scivita Medical Technology Co., Ltd. | 4K UHD Camera System | 08/21/2020 |
| K173111 | Sejong Medical Co., Ltd. | LAP-iX Suction Irrigation | 11/28/2017 |
| K200638 | Sejong Medical Co., Ltd. | LAP-iX Suction Irrigation | 04/03/2020 |
| K970151 | SMITH & NEPHEW, INC. | INTERCEPTRE LAPAROSCOPIC INSTRUMENTS | 03/18/1997 |
| K982149 | SMITH & NEPHEW, INC. | SMITH & NEPHEW DYONICS MICROLAPAROSCOPE | 09/10/1998 |
| K960347 | SPIESS DESIGN, INC. | SAFETY TROCER WITH SPRINGLOADED OBDURATOR | 07/01/1996 |
| K082451 | Stryker Endoscopy | STRYKER VIDEOSCOPE | 12/16/2008 |
| K210116 | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Video Endoscopy System, 3D Video Endoscopy System | 10/13/2021 |
| K091010 | TROKAMED GMBH | TROKAMED MORCELLATOR | 03/01/2011 |
| K061268 | USGI MEDICAL | G-LIX TISSUE GRASPER | 07/31/2006 |
| K163320 | W.O.M. WORLD OF MEDICINE GMBH | LAP-Pump PP110 | 03/21/2017 |
| K990732 | W.O.M. WORLD OF MEDICINE, GMBH | LAP-WAVE 3000 (P07) | 07/23/1999 |
| K964436 | WESTERN SURGICAL INSTRUMENT CO. | WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM | 01/30/1997 |
| K982518 | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH | AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608 | 01/14/1999 |
| K992481 | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH | CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF | 03/17/2000 |
| K982515 | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH | POWER-DRIVE, WISAP MODEL #7688PD/7688PD1 | 01/19/1999 |
| K960640 | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH | S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION) | 02/14/1997 |
| K992513 | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH | THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF | 03/17/2000 |
| K993653 | XOMED, INC. | MICRO-FRANCE TROCARS AND ACCESSORIES | 06/09/2000 |
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