HIH
- Product code
- HIH
- Device name
- Hysteroscope (And Accessories)
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 15
- Summaries archived here
- 12 (direct download)
- 510(k) clearances (all years, FDA)
- 172 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (15)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260984 | 2026-08-18 | Axora Medical, Inc. | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Re… | |
| K253020 | 2026-06-04 | American Medical Endoscopy, Inc. | Strauss Surgical Resection Instruments | — |
| K254050 | 2026-05-15 | Suzhou AcuVu Medical Technology Co., L… | Manual Tissue Removal Device | |
| K254251 | 2026-02-26 | Shanghai AnQing Medical Instrument Co.… | InnovexView (GC146-17, GC150-20, GC155-23) | FDA |
| K252793 | 2025-12-18 | Jiangsu Jiyuan Medical Technology Co.,… | ARMI® Endoscopic Video Image Processor (JY-MIP-3000)… | |
| K252012 | 2025-07-18 | Stryker Endoscopy | SPY Cystoscope/Hysteroscope | |
| K243382 | 2025-06-03 | Rz Medizintechnik GmbH | RZ Resectoscope System | |
| K240978 | 2024-08-16 | MacroLux Medical Technology Co., Ltd. | SeleneView® Single-Use Digital Hysteroscope (HC29, H… | |
| K241987 | 2024-08-02 | Guangzhou Red Pine Medical Instrument … | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) | |
| K240401 | 2024-07-26 | Origyn Medical Technology (Hangzhou) C… | ClearVision Single Use Hysteroscope & Image Process… | |
| K231260 | 2024-03-05 | Suzhou AcuVu Medical Technology Co., L… | HTx Disposable Hysteroscope System | |
| K233635 | 2024-02-12 | Stryker Endoscopy | SPY Cystoscope/Hysteroscope | |
| K232003 | 2024-02-12 | Guangzhou Red Pine Medical Instrument … | Endoscopic Video Image Processor, Single-Use Video H… | |
| K233500 | 2023-11-30 | Caldera Medical, Inc. | Benesta Tissue Removal Device | — |
| K223885 | 2023-09-14 | Karl Storz Endoscopy America, Inc. | HOPKINS Telescopes |
Official FDA classification page: HIH
Classification and pathway per current FDA publications. Data from openFDA (CC0).