The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Gelpoint Transvaginal Access Platform.
| Device ID | K143308 |
| 510k Number | K143308 |
| Device Name: | GelPOINT Transvaginal Access Platform |
| Classification | Culdoscope (and Accessories) |
| Applicant | APPLIED MEDICAL RESOURCES 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Frans Vandenbroek |
| Correspondent | Frans Vandenbroek APPLIED MEDICAL RESOURCES 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 | 2014-11-18 |
| Decision Date | 2015-10-13 |
| Summary: | summary |