FDA Product Code
FDA Product Code HIH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.1690
510(k) Clearances — 175 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254252 | UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) | Karl Storz SE & CO. KG | 2026-09-25 | Traditional | PDF ↗ |
| K261102 | UNIDRIVE Select System | Karl Storz SE & CO. KG | 2026-09-18 | Traditional | PDF ↗ |
| K254294 | Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30) | Zhejiang Geyi Medical Instrument Co., Ltd. | 2026-09-08 | Traditional | PDF ↗ |
| K260984 | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) | Axora Medical, Inc. | 2026-08-18 | Traditional | PDF ↗ |
| K253020 | Strauss Surgical Resection Instruments | American Medical Endoscopy, Inc. | 2026-06-04 | Traditional | PDF ↗ |
| K254050 | Manual Tissue Removal Device | Suzhou AcuVu Medical Technology Co., Ltd. | 2026-05-15 | Traditional | PDF ↗ |
| K254251 | InnovexView (GC146-17, GC150-20, GC155-23) | Shanghai AnQing Medical Instrument Co., Ltd. | 2026-02-26 | Traditional | PDF ↗ |
| K252793 | ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C) | Jiangsu Jiyuan Medical Technology Co., Ltd. | 2025-12-18 | Traditional | PDF ↗ |
| K252012 | SPY Cystoscope/Hysteroscope | Stryker Endoscopy | 2025-07-18 | Special | PDF ↗ |
| K243382 | RZ Resectoscope System | Rz Medizintechnik GmbH | 2025-06-03 | Traditional | PDF ↗ |
| K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) | MacroLux Medical Technology Co., Ltd. | 2024-08-16 | Traditional | PDF ↗ |
| K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-08-02 | Special | PDF ↗ |
| K240401 | ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) | Origyn Medical Technology (Hangzhou) Co., Ltd. | 2024-07-26 | Traditional | PDF ↗ |
| K231260 | HTx Disposable Hysteroscope System | Suzhou AcuVu Medical Technology Co., Ltd. | 2024-03-05 | Traditional | PDF ↗ |
| K232003 | Endoscopic Video Image Processor, Single-Use Video Hysteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-02-12 | Traditional | PDF ↗ |
| K233635 | SPY Cystoscope/Hysteroscope | Stryker Endoscopy | 2024-02-12 | Traditional | PDF ↗ |
| K233500 | Benesta Tissue Removal Device | Caldera Medical, Inc. | 2023-11-30 | Special | PDF ↗ |
| K223885 | HOPKINS Telescopes | Karl Storz Endoscopy America, Inc. | 2023-09-14 | Traditional | PDF ↗ |
| K223813 | Aveta System 2.0 | Meditrina, Inc. | 2023-08-21 | Traditional | PDF ↗ |
| K223520 | UNIDRIVE SIII System | Karl Storz-Endoscopy-America, Inc. | 2023-04-27 | Traditional | PDF ↗ |
| K221557 | Visera Hysterovideoscope Olympus HYF Type V | Olympus Medical Systems Corporation | 2022-09-02 | Traditional | PDF ↗ |
| K213171 | Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) | Meditrina, Inc. | 2022-05-26 | Traditional | PDF ↗ |
| K213207 | Sheath, Stopcock Accessory | Olympus Winter & Ibe GmbH | 2021-12-22 | Traditional | PDF ↗ |
| K202445 | Hystero-V Hysteroscope | Hysterovue, Inc. | 2021-11-23 | Traditional | PDF ↗ |
| K210270 | Medical Endoscope Image Processing System | Jiangsu Jiyuan Medical Technology Co., Ltd. | 2021-10-01 | Traditional | PDF ↗ |
| K211227 | HTx Disposable Hysteroscope System | Acuvu, Inc. | 2021-09-15 | Traditional | PDF ↗ |
| K192811 | BenestaTM Tissue Removal Device | Caldera Medical, Inc. | 2020-10-23 | Traditional | PDF ↗ |
| K201970 | Schoelly Cystoscopes/Hysteroscopes and Accessories | Schoelly Fiberoptic GmbH | 2020-10-08 | Traditional | PDF ↗ |
| K201756 | 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 | Stryker Sustainability Solutions | 2020-09-25 | Traditional | PDF ↗ |
| K192822 | Benesta Hysteroscope | Caldera Medical, Inc. | 2020-09-09 | Traditional | PDF ↗ |
| K200038 | Endosee System | CooperSurgical, Inc. | 2020-02-05 | Special | PDF ↗ |
| K193007 | LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module | Lina Medical Aps | 2020-01-17 | Traditional | PDF ↗ |
| K191538 | Resectr Tissue Resection Device | Boston Scientific Corporation | 2020-01-16 | Traditional | PDF ↗ |
| K192100 | Aveta Disposable Hysteroscope | Meditrina, Inc. | 2019-12-19 | Special | PDF ↗ |
| K190797 | Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) | Reed Medical (Zhejiang) Co., Ltd. | 2019-11-18 | Traditional | PDF ↗ |
| K192278 | Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) | Uvision360, Inc. | 2019-11-01 | Special | PDF ↗ |
| K191958 | Aveta System | Meditrina, Inc. | 2019-10-01 | Special | PDF ↗ |
| K191281 | Omni Hysteroscope, Omni Lok cervical seal | Hologic, Inc. | 2019-08-29 | Traditional | PDF ↗ |
| K191335 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | Corinth Medtech, Inc. | 2019-06-06 | Special | PDF ↗ |
| K190827 | Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid | Uvision360, Inc. | 2019-06-06 | Special | PDF ↗ |
| K182975 | MAKO 7 | Boston Scientific Corporation | 2019-05-21 | Traditional | PDF ↗ |
| K190372 | Aveta System | Meditrina, Inc. | 2019-05-16 | Traditional | PDF ↗ |
| K190639 | Endosee System | CooperSurgical, Inc. | 2019-05-15 | Special | PDF ↗ |
| K181545 | Hysteroscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2019-05-10 | Traditional | PDF ↗ |
| K190113 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | Corinth Medtech, Inc. | 2019-04-24 | Traditional | PDF ↗ |
| K183020 | Endosee System | CooperSurgical, Inc. | 2019-01-31 | Traditional | PDF ↗ |
| K182675 | Polygon Resection Device | Polygon Medical, Inc. | 2019-01-04 | Traditional | PDF ↗ |
| K182006 | Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths | Hologic, Inc. | 2018-12-06 | Special | PDF ↗ |
| K180496 | TruClear Elite Hysteroscope | Covidien | 2018-08-29 | Traditional | PDF ↗ |
| K181974 | MyoSure XL Tissue Removal Device for Fluent | Hologic, Inc. | 2018-08-23 | Special | PDF ↗ |
| K180752 | Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole | Corinth Medtech, Inc. | 2018-07-25 | Traditional | PDF ↗ |
| K173070 | HSW Resection Instruments | Henke-Sass, Wolf GmbH | 2018-06-08 | Traditional | PDF ↗ |
| K173901 | MyoSure MANUAL Tissue Removal Device | Hologic, Inc. | 2018-05-08 | Traditional | PDF ↗ |
| K180096 | GDT-1000 System | Acuvu, Inc. | 2018-04-16 | Traditional | PDF ↗ |
| K171113 | 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 | Lina Medical Aps | 2018-01-04 | Traditional | PDF ↗ |
| K172566 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices | Hologic, Inc. | 2017-09-20 | Special | PDF ↗ |
| K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | CooperSurgical, Inc. | 2017-07-13 | Traditional | PDF ↗ |
| K161763 | Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device | Smith & Nephew, Inc. | 2016-11-22 | Traditional | PDF ↗ |
| K160751 | Symphion Endoscope and Symphion Cervical Sheath | Boston Scientific | 2016-06-14 | Traditional | PDF ↗ |
| K160510 | MAKO 7 | Nvision Medical Corporation | 2016-06-09 | Traditional | PDF ↗ |
| K152723 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices | Hologic, Inc. | 2015-11-13 | Special | PDF ↗ |
| K151275 | MAKO Device | Nvision Medical | 2015-11-13 | Traditional | PDF ↗ |
| K152143 | TRUCLEAR Operative Hysteroscope 5C and Sheath 5C | Smith & Nephew, Inc. | 2015-09-02 | Special | PDF ↗ |
| K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | Schoelly Fiberoptic GmbH | 2015-03-09 | Traditional | PDF ↗ |
| K141515 | AED HYSTEROSCOPE AND ACCESSORIES | National Advanced Endoscopy Devices, Inc. | 2015-01-07 | Traditional | PDF ↗ |
| K142029 | MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM | Hologic, Inc. | 2014-11-26 | Traditional | PDF ↗ |
| K132384 | U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA | Endosec Corporation | 2014-07-02 | Traditional | PDF ↗ |
| K132015 | TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS | Smith & Nephew, Inc. | 2013-12-13 | Traditional | PDF ↗ |
| K131581 | MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) | Hologic, Inc. | 2013-08-22 | Special | PDF ↗ |
| K131736 | MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK) | Hologic, Inc. | 2013-08-22 | Special | PDF ↗ |
| K123330 | IOGYN ENDOSCOPE | Iogyn, Inc. | 2013-03-19 | Traditional | PDF ↗ |
| K123151 | ENDOSEE MODEL 8000 U-SCOPE | Endosee Corp | 2013-03-08 | Traditional | PDF ↗ |
| K122563 | MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL | Hologic, Inc. | 2012-09-19 | Special | PDF ↗ |
| K122498 | MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK) | Hologic, Inc. | 2012-09-10 | Special | PDF ↗ |
| K121868 | MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK) | Hologic, Inc. | 2012-07-19 | Special | PDF ↗ |
| K120593 | MYOSURE CONTROL UNIT | Hologic, Inc. | 2012-03-23 | Special | PDF ↗ |
| K112134 | TRUCLEAR OPERATIVE HYSTEROSCOPE | Smith & Nephew, Inc. | 2011-11-22 | Traditional | PDF ↗ |
| K110038 | TRUCLEAR MORCELLATOR SYSTEM | Smith & Nephew, Inc. | 2011-03-30 | Special | PDF ↗ |
| K103389 | TRUCLEAR INCISOR PLUS BLADE 2.9 | Smith & Nephew, Inc. | 2011-03-25 | Traditional | PDF ↗ |
| K102686 | MYOSURE ROD LENS SCOPE SEALS | Interlace Medical, Inc. | 2010-10-15 | Special | PDF ↗ |
| K093218 | FEMEYE TWO | Fem Suite, LLC | 2010-05-18 | Traditional | PDF ↗ |
| K100559 | MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM | Interlace Medical, Inc. | 2010-03-30 | Special | PDF ↗ |
| K092421 | ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC | Gimmi GmbH | 2010-02-12 | Abbreviated | PDF ↗ |
| K091838 | OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK | Obp Medical | 2009-12-04 | Traditional | PDF ↗ |
| K091100 | MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM | Interlace Medical, Inc. | 2009-10-23 | Traditional | PDF ↗ |
| K092278 | GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 | Gyrus Acmi, Inc. | 2009-09-29 | Traditional | PDF ↗ |
| K091465 | MYOSURE ROD LENS HYSTEROSCOPE | Interlace Medical, Inc. | 2009-08-21 | Traditional | PDF ↗ |
| K081070 | INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM | Interlace Medical, Inc. | 2008-07-23 | Traditional | PDF ↗ |
| K073690 | INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM | Interlace Medical, Inc. | 2008-04-17 | Traditional | PDF ↗ |
| K071127 | FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM | Vision-Sciences, Inc. | 2007-11-16 | Traditional | PDF ↗ |
| K053583 | OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL | Optivia Medical, LLC | 2006-03-31 | Traditional | PDF ↗ |
| K041774 | IUR RECIPROCATING MORCELLATOR MODEL # 7210517 | Smith & Nephew, Inc. | 2004-10-07 | Traditional | PDF ↗ |
| K040390 | STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM | Stryker Endoscopy | 2004-05-17 | Traditional | PDF ↗ |
| K040302 | VERSAPOINT RESECTOSCOPIC SYSTEM | Gynecare, A Div. of Ethicon, Inc. | 2004-03-09 | Special | PDF ↗ |
| K033113 | UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753 | Richard Wolf Medical Instruments Corp. | 2003-12-23 | Traditional | PDF ↗ |
| K031787 | SMITH & NEPHEW IUR MORCELLATION SYSTEM | Smith & Nephew, Inc. | 2003-12-02 | Traditional | PDF ↗ |
| K031974 | ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0 | Asap Endoscopic Products GmbH | 2003-09-29 | Traditional | PDF ↗ |
| K022445 | VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V | Olympus Optical Co., Ltd. | 2003-01-24 | Traditional | PDF ↗ |
| K022480 | ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC | Acmi Corporation | 2002-08-22 | Special | PDF ↗ |
| K012869 | GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25 | Gimmi GmbH | 2002-03-11 | Abbreviated | PDF ↗ |
Product code HIH · Class II · Obstetrics/Gynecology. Data: openFDA.