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Panels › Obstetrics/Gynecology › Product code HIH · Class 2

Hysteroscope (And Accessories)

Regulation 884.1690

8510(k)s in 12 months (175 all time)
4recalls in 12 months (16 all time)
16recalls that name a 510(k)
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Top companies in HIH

Company510(k)sRecalls
Hologic, Inc.130
KARL STORZ Endoscopy-America, Inc.110
Smith & Nephew, Inc.100
CooperSurgical, Inc.52
Olympus Corporation of the Americas07
Richard Wolf Medical Instruments Corp.61
Interlace Medical, Inc.60
Imagyn Medical, Inc.50
Meditrina, Inc.50
Karl Storz Endoscopy31
Decided510(k)Device and applicantCode
Sep 25, 2026K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205
Karl Storz SE & CO. KG, DE
HIH
Sep 18, 2026K261102UNIDRIVE Select System
Karl Storz SE & CO. KG, DE
HIH
Sep 8, 2026K254294Single-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, GYU
Zhejiang Geyi Medical Instrument Co., Ltd., CN
HIH
Aug 18, 2026K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)
Axora Medical, Inc.
HIH
Jun 4, 2026K253020Strauss Surgical Resection Instruments
American Medical Endoscopy, Inc.
HIH
May 15, 2026K254050Manual Tissue Removal Device
Suzhou AcuVu Medical Technology Co., Ltd., CN
HIH
Feb 26, 2026K254251InnovexView (GC146-17, GC150-20, GC155-23)
Shanghai AnQing Medical Instrument Co., Ltd., CN
HIH
Dec 18, 2025K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-
Jiangsu Jiyuan Medical Technology Co., Ltd., CN
HIH
Jul 18, 2025K252012SPY Cystoscope/Hysteroscope
Stryker Endoscopy
HIH
Jun 3, 2025K243382RZ Resectoscope System
Rz Medizintechnik GmbH, DE
HIH
Aug 16, 2024K240978SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
MacroLux Medical Technology Co., Ltd., CN
HIH
Aug 2, 2024K241987Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
Guangzhou Red Pine Medical Instrument Co., Ltd., CN
HIH
Jul 26, 2024K240401ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
Origyn Medical Technology (Hangzhou) Co., Ltd., CN
HIH
Mar 5, 2024K231260HTx Disposable Hysteroscope System
Suzhou AcuVu Medical Technology Co., Ltd., CN
HIH
Feb 12, 2024K233635SPY Cystoscope/Hysteroscope
Stryker Endoscopy
HIH
Feb 12, 2024K232003Endoscopic Video Image Processor, Single-Use Video Hysteroscope
Guangzhou Red Pine Medical Instrument Co., Ltd., CN
HIH
Nov 30, 2023K233500Benesta Tissue Removal Device
Caldera Medical, Inc.
HIH
Sep 14, 2023K223885HOPKINS Telescopes
Karl Storz Endoscopy America, Inc.
HIH
Aug 21, 2023K223813Aveta System 2.0
Meditrina, Inc.
HIH
Apr 27, 2023K223520UNIDRIVE SIII System
Karl Storz-Endoscopy-America, Inc.
HIH
Sep 2, 2022K221557Visera Hysterovideoscope Olympus HYF Type V
Olympus Medical Systems Corporation, JP
HIH
May 26, 2022K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)
Meditrina, Inc.
HIH
Dec 22, 2021K213207Sheath, Stopcock Accessory
Olympus Winter & Ibe GmbH, DE
HIH
Nov 23, 2021K202445Hystero-V Hysteroscope
Hysterovue, Inc.
HIH
Oct 1, 2021K210270Medical Endoscope Image Processing System
Jiangsu Jiyuan Medical Technology Co., Ltd., CN
HIH
Sep 15, 2021K211227HTx Disposable Hysteroscope System
Acuvu, Inc.
HIH
Oct 23, 2020K192811BenestaTM Tissue Removal Device
Caldera Medical, Inc.
HIH
Oct 8, 2020K201970Schoelly Cystoscopes/Hysteroscopes and Accessories
Schoelly Fiberoptic GmbH, DE
HIH
Sep 25, 2020K201756Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tis
Stryker Sustainability Solutions
HIH
Sep 9, 2020K192822Benesta Hysteroscope
Caldera Medical, Inc.
HIH
Feb 5, 2020K200038Endosee System
CooperSurgical, Inc.
HIH
Jan 17, 2020K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module
Lina Medical Aps, DK
HIH
Jan 16, 2020K191538Resectr Tissue Resection Device
Boston Scientific Corporation
HIH
Dec 19, 2019K192100Aveta Disposable Hysteroscope
Meditrina, Inc.
HIH
Nov 18, 2019K190797Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)
Reed Medical (Zhejiang) Co., Ltd., CN
HIH
Nov 1, 2019K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)
Uvision360, Inc.
HIH
Oct 1, 2019K191958Aveta System
Meditrina, Inc.
HIH
Aug 29, 2019K191281Omni Hysteroscope, Omni Lok cervical seal
Hologic, Inc.
HIH
Jun 6, 2019K191335Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll S
Corinth Medtech, Inc.
HIH
Jun 6, 2019K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
Uvision360, Inc.
HIH
May 21, 2019K182975MAKO 7
Boston Scientific Corporation
HIH
May 16, 2019K190372Aveta System
Meditrina, Inc.
HIH
May 15, 2019K190639Endosee System
CooperSurgical, Inc.
HIH
May 10, 2019K181545Hysteroscope System
Shanghai AnQing Medical Instrument Co., Ltd., CN
HIH
Apr 24, 2019K190113Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll S
Corinth Medtech, Inc.
HIH
Jan 31, 2019K183020Endosee System
CooperSurgical, Inc.
HIH
Jan 4, 2019K182675Polygon Resection Device
Polygon Medical, Inc.
HIH
Dec 6, 2018K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
Hologic, Inc.
HIH
Aug 29, 2018K180496TruClear Elite Hysteroscope
Covidien
HIH
Aug 23, 2018K181974MyoSure XL Tissue Removal Device for Fluent
Hologic, Inc.
HIH

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