The following data is part of a premarket notification filed by Applied Medical Resources Corporation with the FDA for Gelpoint V-path Vaginal Access System.
| Device ID | K220969 |
| 510k Number | K220969 |
| Device Name: | GelPOINT V-Path Vaginal Access System |
| Classification | Culdoscope (and Accessories) |
| Applicant | Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | David Yu |
| Correspondent | David Yu Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | HEW |
| CFR Regulation Number | 884.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-04 |
| Decision Date | 2022-09-16 |