HIH · Hysteroscope (And Accessories)
Obstetrics/Gynecology · 21 CFR 884.1690 · Class 2
Overview
| Product Code | HIH |
|---|---|
| Device Name | Hysteroscope (And Accessories) |
| Regulation | 21 CFR 884.1690 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.
Classification Rationale
(1) Class II (performance standards). (2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
Recent Cleared Devices (20 of 169)
Showing 20 most recent of 169 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254251 | InnovexView (GC146-17, GC150-20, GC155-23) | Shanghai AnQing Medical Instrument Co., Ltd. | Feb 26, 2026 | SESE |
| 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. | Dec 18, 2025 | SESE |
| K252012 | SPY Cystoscope/Hysteroscope | Stryker Endoscopy | Jul 18, 2025 | SESE |
| K243382 | RZ Resectoscope System | Rz Medizintechnik GmbH | Jun 3, 2025 | SESE |
| K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) | MacroLux Medical Technology Co., Ltd. | Aug 16, 2024 | SESE |
| K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) | Guangzhou Red Pine Medical Instrument Co., Ltd. | Aug 2, 2024 | SESE |
| K240401 | ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) | Origyn Medical Technology (Hangzhou) Co., Ltd. | Jul 26, 2024 | SESE |
| K231260 | HTx Disposable Hysteroscope System | Suzhou AcuVu Medical Technology Co., Ltd. | Mar 5, 2024 | SESE |
| K233635 | SPY Cystoscope/Hysteroscope | Stryker Endoscopy | Feb 12, 2024 | SESE |
| K232003 | Endoscopic Video Image Processor, Single-Use Video Hysteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | Feb 12, 2024 | SESE |
| K233500 | Benesta Tissue Removal Device | Caldera Medical, Inc. | Nov 30, 2023 | SESE |
| K223885 | HOPKINS Telescopes | Karl Storz Endoscopy America, Inc. | Sep 14, 2023 | SESE |
| K223813 | Aveta System 2.0 | Meditrina, Inc. | Aug 21, 2023 | SESE |
| K223520 | UNIDRIVE SIII System | Karl Storz-Endoscopy-America, Inc. | Apr 27, 2023 | SESE |
| K221557 | Visera Hysterovideoscope Olympus HYF Type V | Olympus Medical Systems Corporation | Sep 2, 2022 | SESE |
| K213171 | Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) | Meditrina, Inc. | May 26, 2022 | SESE |
| K213207 | Sheath, Stopcock Accessory | Olympus Winter & Ibe GmbH | Dec 22, 2021 | SESE |
| K202445 | Hystero-V Hysteroscope | Hysterovue, Inc. | Nov 23, 2021 | SESE |
| K210270 | Medical Endoscope Image Processing System | Jiangsu Jiyuan Medical Technology Co., Ltd. | Oct 1, 2021 | SESE |
| K211227 | HTx Disposable Hysteroscope System | Acuvu, Inc. | Sep 15, 2021 | SESE |
Top Applicants
- Hologic, Inc. — 13 clearances
- Smith & Nephew, Inc. — 10 clearances
- KARL STORZ Endoscopy-America, Inc. — 9 clearances
- Interlace Medical, Inc. — 6 clearances
- Richard Wolf Medical Instruments Corp. — 6 clearances
