K220969 is an FDA 510(k) clearance for the GelPOINT V-Path Vaginal Access System. This device is classified as a Vaginoscope And Accessories (Class II - Special Controls, product code MOK).
Submitted by Applied Medical Resources Corporation (Rancho Santa, US). The FDA issued a Cleared decision on September 16, 2022, 165 days after receiving the submission on April 4, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1630.
| 510(k) Number | K220969 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2022 |
| Decision Date | September 16, 2022 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MOK — Vaginoscope And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1630 |