K240401 is an FDA 510(k) clearance for the ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US). This device is classified as a Hysteroscope (and Accessories) (Class II - Special Controls, product code HIH).
Submitted by Origyn Medical Technology (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on July 26, 2024, 168 days after receiving the submission on February 9, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K240401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2024 |
| Decision Date | July 26, 2024 |
| Days to Decision | 168 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 |