K160341 is an FDA 510(k) clearance for the Colposcope System. This device is classified as a Colposcope (and Colpomicroscope) (Class II - Special Controls, product code HEX).
Submitted by Xuzhou Kernel Medical Equipment Co., Ltd. (Xuzhou, CN). The FDA issued a Cleared decision on September 14, 2016, 219 days after receiving the submission on February 8, 2016.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1630.
| 510(k) Number | K160341 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2016 |
| Decision Date | September 14, 2016 |
| Days to Decision | 219 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 |