K151878 is an FDA 510(k) clearance for the Video Colposcope. This device is classified as a Colposcope (and Colpomicroscope) (Class II - Special Controls, product code HEX).
Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on December 1, 2015, 145 days after receiving the submission on July 9, 2015.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1630.
| 510(k) Number | K151878 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2015 |
| Decision Date | December 01, 2015 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HEX — Colposcope (and Colpomicroscope) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1630 |