FDA 510(k) Applications for Medical Device Product Code "HIH"
(Hysteroscope (And Accessories))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K022480 | ACMI CORPORATION | ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC | 08/22/2002 |
| K180096 | AcuVu Inc. | GDT-1000 System | 04/16/2018 |
| K211227 | AcuVu Inc. | HTx Disposable Hysteroscope System | 09/15/2021 |
| K031974 | ASAP ENDOSCOPIC PRODUCTS GMBH | ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0 | 09/29/2003 |
| K160751 | BOSTON SCIENTIFIC | Symphion Endoscope and Symphion Cervical Sheath | 06/14/2016 |
| K182975 | Boston Scientific Corporation | MAKO 7 | 05/21/2019 |
| K191538 | Boston Scientific Corporation | Resectr Tissue Resection Device | 01/16/2020 |
| K192822 | Caldera Medical, Inc. | Benesta Hysteroscope | 09/09/2020 |
| K192811 | Caldera Medical, Inc. | BenestaTM Tissue Removal Device | 10/23/2020 |
| K954164 | CONCEPTUS, INC. | HYSTEROSCOPE | 03/12/1996 |
| K972210 | CONCEPTUS, INC. | RESECTOSCOPE SAFETY SHEATH | 09/05/1997 |
| K170660 | CooperSurgical, Inc. | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | 07/13/2017 |
| K183020 | CooperSurgical, Inc. | Endosee System | 01/31/2019 |
| K190639 | CooperSurgical, Inc. | Endosee System | 05/15/2019 |
| K200038 | CooperSurgical, Inc. | Endosee System | 02/05/2020 |
| K190113 | Corinth MedTech, Inc. | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | 04/24/2019 |
| K191335 | Corinth MedTech, Inc. | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | 06/06/2019 |
| K180752 | Corinth MedTech, Inc. | Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole | 07/25/2018 |
| K180496 | Covidien | TruClear Elite Hysteroscope | 08/29/2018 |
| K132384 | ENDOSEC CORPORATION | U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA | 07/02/2014 |
| K123151 | ENDOSEE CORP | ENDOSEE MODEL 8000 U-SCOPE | 03/08/2013 |
| K981800 | EQUAL DIAGNOSTICS, INC. | SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606 | 07/06/1998 |
| K994418 | ETHICON, INC. | VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) | 01/24/2000 |
| K093218 | FEMSUITE, LLC | FEMEYE TWO | 05/18/2010 |
| K962256 | GALILEO ELECTRO-OPTICS CORP. | GALILEO HYSTEROSCOPES AND LAPAROSCOPES | 12/06/1996 |
| K092421 | GIMMI GMBH | ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC | 02/12/2010 |
| K012869 | GIMMI GMBH | GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25 | 03/11/2002 |
| K003802 | GLOBAL ENDOSCOPY, INC. | HYSTEROSCOPES | 07/22/2001 |
| K971305 | GYNECARE INNOVATION CENTER | FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM | 08/11/1997 |
| K954648 | GYNECARE INNOVATION CENTER | FEMRX OPERASTAR SYSTEM | 03/14/1996 |
| K040302 | GYNECARE, A DIV. OF ETHICON, INC. | VERSAPOINT RESECTOSCOPIC SYSTEM | 03/09/2004 |
| K992901 | GYNECARE, INC. | GYNECARE VERSAPOINT G-VAP ELECTRODE | 01/18/2000 |
| K962482 | GYNECARE, INC. | SCUBA SYSTEM | 11/01/1996 |
| K982738 | GYNECARE, INC. | VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) | 03/01/1999 |
| K092278 | GYRUS ACMI, INC. | GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 | 09/29/2009 |
| K982771 | GYRUS MEDICAL LTD. | GYRUS HYSTEROSCOPIC RESECTOSCOPE | 01/21/1999 |
| K993749 | GYRUS MEDICAL LTD. | GYRUS HYSTEROSCOPIC RESECTOSCOPE | 12/03/1999 |
| K991563 | HENKE SASS WOLF OF AMERICA, INC. | CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C | 10/13/1999 |
| K952186 | HENKE-SASS WOLF, GMBH. | HSW GMBH HYSTEROSCOPES & ACCESSORIES | 02/06/1996 |
| K173070 | Henke-Sass, Wolf GmbH | HSW Resection Instruments | 06/08/2018 |
| K152723 | HOLOGIC, INC | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices | 11/13/2015 |
| K181974 | Hologic, Inc | MyoSure XL Tissue Removal Device for Fluent | 08/23/2018 |
| K182006 | Hologic, Inc | Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths | 12/06/2018 |
| K120593 | HOLOGIC, INC. | MYOSURE CONTROL UNIT | 03/23/2012 |
| K142029 | HOLOGIC, INC. | MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM | 11/26/2014 |
| K172566 | Hologic, Inc. | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices | 09/20/2017 |
| K121868 | HOLOGIC, INC. | MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK) | 07/19/2012 |
| K173901 | Hologic, Inc. | MyoSure MANUAL Tissue Removal Device | 05/08/2018 |
| K131581 | HOLOGIC, INC. | MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) | 08/22/2013 |
| K131736 | HOLOGIC, INC. | MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK) | 08/22/2013 |
| K122563 | HOLOGIC, INC. | MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL | 09/19/2012 |
| K122498 | HOLOGIC, INC. | MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK) | 09/10/2012 |
| K191281 | Hologic, Inc. | Omni Hysteroscope, Omni Lok cervical seal | 08/29/2019 |
| K202445 | Hysterovue, Inc. | Hystero-V Hysteroscope | 11/23/2021 |
| K972426 | IMAGYN MEDICAL, INC. | MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH | 09/23/1997 |
| K961688 | IMAGYN MEDICAL, INC. | MICROSPAN HYSTEROSCOPE | 10/15/1996 |
| K961506 | IMAGYN MEDICAL, INC. | MICROSPAN HYSTEROSCOPE SHEATH | 07/03/1996 |
| K100559 | INTERLACE MEDICAL INC. | MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM | 03/30/2010 |
| K073690 | INTERLACE MEDICAL, INC. | INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM | 04/17/2008 |
| K081070 | INTERLACE MEDICAL, INC. | INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM | 07/23/2008 |
| K091100 | INTERLACE MEDICAL, INC. | MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM | 10/23/2009 |
| K091465 | INTERLACE MEDICAL, INC. | MYOSURE ROD LENS HYSTEROSCOPE | 08/21/2009 |
| K102686 | INTERLACE MEDICAL, INC. | MYOSURE ROD LENS SCOPE SEALS | 10/15/2010 |
| K123330 | IOGYN, INC. | IOGYN ENDOSCOPE | 03/19/2013 |
| K210270 | Jiangsu Jiyuan Medical Technology Co., Ltd. | Medical Endoscope Image Processing System | 10/01/2021 |
| K992027 | KARL STORZ ENDOSCOPY | KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR | 09/09/1999 |
| K990411 | KARL STORZ ENDOSCOPY | MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE | 05/11/1999 |
| K223885 | Karl Storz Endoscopy America, Inc. | HOPKINS Telescopes | 09/14/2023 |
| K961605 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE | 11/13/1996 |
| K983901 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA HF-SNARE | 02/01/1999 |
| K001740 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA MONOPOLAR VAPORIZATION ELECTRODES | 08/22/2000 |
| K983569 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA MONOPOLAR VAPORIZATION ELECTRODES | 01/08/1999 |
| K971518 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES | 07/24/1997 |
| K223520 | Karl Storz-Endoscopy-America, Inc. | UNIDRIVE SIII System | 04/27/2023 |
| K193007 | LiNA Medical ApS | LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module | 01/17/2020 |
| K171113 | LiNA Medical ApS | LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module | 01/04/2018 |
| K192100 | Meditrina, Inc. | Aveta Disposable Hysteroscope | 12/19/2019 |
| K191958 | Meditrina, Inc. | Aveta System | 10/01/2019 |
| K190372 | Meditrina, Inc. | Aveta System | 05/16/2019 |
| K223813 | Meditrina, Inc. | Aveta System 2.0 | 08/21/2023 |
| K213171 | Meditrina, Inc. | Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) | 05/26/2022 |
| K982659 | MEDIVISION SCOPE SERVICE CENTER, INC. | MEDIVISION HYSTEROSCOPE | 10/07/1998 |
| K990910 | MTP MEDICAL TECHNICAL PROMOTION GMBH | MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS | 06/03/1999 |
| K141515 | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | AED HYSTEROSCOPE AND ACCESSORIES | 01/07/2015 |
| K974297 | NETOPTIX CORP. | GALILEO DISPOSABLE HYSTEROSCOPES | 02/13/1998 |
| K981828 | NETOPTIX CORP. | GALILEO DISPOSABLE HYSTEROSCOPES | 07/07/1998 |
| K962271 | NORTHGATE TECHNOLOGIES, INC. | ELECTROSURGICAL ELECRTRODES | 08/08/1997 |
| K151275 | nVision Medical | MAKO Device | 11/13/2015 |
| K160510 | nVision Medical Corporation | MAKO 7 | 06/09/2016 |
| K091838 | OBP MEDICAL | OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK | 12/04/2009 |
| K954488 | OLYMPUS AMERICA, INC. | ROLLER ELECTRODE | 03/06/1997 |
| K221557 | Olympus Medical Systems Corporation | Visera Hysterovideoscope Olympus HYF Type V | 09/02/2022 |
| K022445 | OLYMPUS OPTICAL CO., LTD. | VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V | 01/24/2003 |
| K213207 | Olympus Winter & Ibe GmbH | Sheath, Stopcock Accessory | 12/22/2021 |
| K053583 | OPTIVIA MEDICAL LLC | OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL | 03/31/2006 |
| K182675 | Polygon Medical, Inc. | Polygon Resection Device | 01/04/2019 |
| K190797 | Reed Medical (Zhejiang) Co., Ltd. | Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) | 11/18/2019 |
| K000673 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241 | 05/26/2000 |
| K971420 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS CANNULA(8755.211,212) | 10/22/1997 |
| K033113 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753 | 12/23/2003 |
| K980302 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES | 07/20/1998 |
| K150158 | Schoelly Fiberoptic GmbH | Schoelly Cystoscopes/Hysteroscopes and Accessories | 03/09/2015 |
| K201970 | Schoelly Fiberoptic GmbH | Schoelly Cystoscopes/Hysteroscopes and Accessories | 10/08/2020 |
| K181545 | Shanghai AnQing Medical Instrument CO., Ltd. | Hysteroscope System | 05/10/2019 |
| K041774 | SMITH & NEPHEW, INC. | IUR RECIPROCATING MORCELLATOR MODEL # 7210517 | 10/07/2004 |
| K971188 | SMITH & NEPHEW, INC. | SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS | 06/27/1997 |
| K031787 | SMITH & NEPHEW, INC. | SMITH & NEPHEW IUR MORCELLATION SYSTEM | 12/02/2003 |
| K013870 | SMITH & NEPHEW, INC. | SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208; SMITH & NEPHEW CONTINUOUS FLOW SHEATH, MODEL 8105224 | 01/17/2002 |
| K161763 | Smith & Nephew, Inc. | Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device | 11/22/2016 |
| K103389 | SMITH & NEPHEW, INC. | TRUCLEAR INCISOR PLUS BLADE 2.9 | 03/25/2011 |
| K132015 | SMITH & NEPHEW, INC. | TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS | 12/13/2013 |
| K110038 | SMITH & NEPHEW, INC. | TRUCLEAR MORCELLATOR SYSTEM | 03/30/2011 |
| K112134 | SMITH & NEPHEW, INC. | TRUCLEAR OPERATIVE HYSTEROSCOPE | 11/22/2011 |
| K152143 | SMITH & NEPHEW, INC. | TRUCLEAR Operative Hysteroscope 5C and Sheath 5C | 09/02/2015 |
| K040390 | Stryker Endoscopy | STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM | 05/17/2004 |
| K201756 | Stryker Sustainability Solutions | Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent | 09/25/2020 |
| K955119 | SYMBIOSIS CORP. | SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES | 01/18/1996 |
| K190827 | UVision360 Inc. | Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid | 06/06/2019 |
| K192278 | UVision360 Inc. | Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) | 11/01/2019 |
| K071127 | VISION-SCIENCES, INC. | FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM | 11/16/2007 |
| K971374 | WILSON GREATBATCH TECHNOLOGIES, INC. | GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE | 05/13/1998 |
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