K254251 is an FDA 510(k) clearance for the InnovexView (GC146-17, GC150-20, GC155-23), a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Shanghai AnQing Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 26, 2026, 59 days after receiving the submission on December 29, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K254251 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 29, 2025 |
| Decision Date | February 26, 2026 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIH — Hysteroscope (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1690 |