K210270 is an FDA 510(k) clearance for the Medical Endoscope Image Processing System, a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Jiangsu Jiyuan Medical Technology Co., Ltd. (Jiangsu, CN). The FDA issued a Cleared decision on October 1, 2021, 242 days after receiving the submission on February 1, 2021. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K210270 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 01, 2021 |
| Decision Date | October 01, 2021 |
| Days to Decision | 242 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 |