K220969 is an FDA 510(k) clearance for the GelPOINT V-Path Vaginal Access System, 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 review panel. Regulated under 21 CFR 884.1630.
| 510(k) Number | K220969 FDA.gov |
| FDA Decision | Cleared 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 |