Product code HIH

Current FDA Classification

Device name
Hysteroscope (And Accessories)
Medical specialty
Obstetrics/Gynecology
Device class
2
Regulation number
884.1690
Review panel
OB
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Ineligible

Related 510(k) Records

510(k)DeviceApplicantDecision date
K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.2026-05-15
K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.2026-02-26
K252793ARMI® 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
K252012SPY Cystoscope/HysteroscopeStryker Endoscopy2025-07-18
K243382RZ Resectoscope SystemRz Medizintechnik GmbH2025-06-03
K240978SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)MacroLux Medical Technology Co., Ltd.2024-08-16
K241987Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)Guangzhou Red Pine Medical Instrument Co., Ltd.2024-08-02
K240401ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)Origyn Medical Technology (Hangzhou) Co., Ltd.2024-07-26
K231260HTx Disposable Hysteroscope SystemSuzhou AcuVu Medical Technology Co., Ltd.2024-03-05
K233635SPY Cystoscope/HysteroscopeStryker Endoscopy2024-02-12
K232003Endoscopic Video Image Processor, Single-Use Video HysteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.2024-02-12
K233500Benesta Tissue Removal DeviceCaldera Medical, Inc.2023-11-30
K223885HOPKINS TelescopesKarl Storz Endoscopy America, Inc.2023-09-14
K223813Aveta System 2.0Meditrina, Inc.2023-08-21
K223520UNIDRIVE SIII SystemKarl Storz-Endoscopy-America, Inc.2023-04-27
K221557Visera Hysterovideoscope Olympus HYF Type VOlympus Medical Systems Corporation2022-09-02
K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)Meditrina, Inc.2022-05-26
K213207Sheath, Stopcock AccessoryOlympus Winter & Ibe GmbH2021-12-22
K202445Hystero-V HysteroscopeHysterovue, Inc.2021-11-23
K210270Medical Endoscope Image Processing SystemJiangsu Jiyuan Medical Technology Co., Ltd.2021-10-01
K211227HTx Disposable Hysteroscope SystemAcuvu, Inc.2021-09-15
K192811BenestaTM Tissue Removal DeviceCaldera Medical, Inc.2020-10-23
K201970Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH2020-10-08
K201756Reprocessed 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 FluentStryker Sustainability Solutions2020-09-25
K192822Benesta HysteroscopeCaldera Medical, Inc.2020-09-09
K200038Endosee SystemCooperSurgical, Inc.2020-02-05
K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording ModuleLina Medical Aps2020-01-17
K191538Resectr Tissue Resection DeviceBoston Scientific Corporation2020-01-16
K192100Aveta Disposable HysteroscopeMeditrina, Inc.2019-12-19
K190797Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)Reed Medical (Zhejiang) Co., Ltd.2019-11-18

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04048551274712NAKarl Storz GmbH & Co. KG2025-03-27
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04048551274736NAKarl Storz GmbH & Co. KG2025-03-27
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00850033976250HERizon Medical Endoscope Image Processor Minerva Surgical, Inc.2024-10-07
04055207023730NARichard Wolf GmbH2016-09-27
04048551093832HOPKINSKarl Storz GmbH & Co. KG2016-09-23
04042761077729OlympusOLYMPUS Winter & Ibe GmbH2016-09-21