HIH — Hysteroscope (And Accessories) Class II
FDA product code HIH covers "Hysteroscope (And Accessories)", a Class II medical device regulated under 21 CFR 884.1690. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HIH
- Device Class
- Class II
- Regulation Number
- 884.1690
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253020 | american medical endoscopy | Strauss Surgical Resection Instruments | June 4, 2026 |
| K254050 | suzhou acuvu medical technology co | Manual Tissue Removal Device | May 15, 2026 |
| K254251 | shanghai anqing medical instrument co | InnovexView (GC146-17, GC150-20, GC155-23) | February 26, 2026 |
| K252793 | jiangsu jiyuan medical technology co | ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysterosc | December 18, 2025 |
| K252012 | stryker endoscopy | SPY Cystoscope/Hysteroscope | July 18, 2025 |
| K243382 | rz medizintechnik | RZ Resectoscope System | June 3, 2025 |
| K240978 | macrolux medical technology co | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, H | August 16, 2024 |
| K241987 | guangzhou red pine medical instrument co | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) | August 2, 2024 |
| K240401 | origyn medical technology (hangzhou) co | ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS- | July 26, 2024 |
| K231260 | suzhou acuvu medical technology co | HTx Disposable Hysteroscope System | March 5, 2024 |
| K232003 | guangzhou red pine medical instrument co | Endoscopic Video Image Processor, Single-Use Video Hysteroscope | February 12, 2024 |
| K233635 | stryker endoscopy | SPY Cystoscope/Hysteroscope | February 12, 2024 |
| K233500 | caldera medical | Benesta Tissue Removal Device | November 30, 2023 |
| K223885 | karl storz endoscopy america | HOPKINS Telescopes | September 14, 2023 |
| K223813 | meditrina | Aveta System 2.0 | August 21, 2023 |
| K223520 | karl storz-endoscopy-america | UNIDRIVE SIII System | April 27, 2023 |
| K221557 | olympus medical systems corporation | Visera Hysterovideoscope Olympus HYF Type V | September 2, 2022 |
| K213171 | meditrina | Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable | May 26, 2022 |
| K213207 | olympus winter and ibe | Sheath, Stopcock Accessory | December 22, 2021 |
| K202445 | hysterovue | Hystero-V Hysteroscope | November 23, 2021 |