K143308 is an FDA 510(k) clearance for the GelPOINT Transvaginal Access Platform. This device is classified as a Culdoscope (and Accessories) (Class II - Special Controls, product code HEW).
Submitted by Applied Medical Resources (Rancho Santa, US). The FDA issued a Cleared decision on October 13, 2015, 329 days after receiving the submission on November 18, 2014.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1640.
| 510(k) Number | K143308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2014 |
| Decision Date | October 13, 2015 |
| Days to Decision | 329 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HEW — Culdoscope (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1640 |