K252793 is an FDA 510(k) clearance for the ARMI® Endoscopic Video Image Processor (JY-MIP-3000). This device is classified as a Hysteroscope (and Accessories) (Class II - Special Controls, product code HIH).
Submitted by Jiangsu Jiyuan Medical Technology Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on December 18, 2025, 111 days after receiving the submission on August 29, 2025.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K252793 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2025 |
| Decision Date | December 18, 2025 |
| Days to Decision | 111 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 |