The following data is part of a premarket notification filed by Gynius Ab with the FDA for The Gynocular.
| Device ID | K132423 |
| 510k Number | K132423 |
| Device Name: | THE GYNOCULAR |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | GYNIUS AB DOBELNSGATAN 23 Stockholm, SE 11140 |
| Contact | Matthew Volsky |
| Correspondent | Matthew Volsky GYNIUS AB DOBELNSGATAN 23 Stockholm, SE 11140 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-05 |
| Decision Date | 2014-04-08 |
| Summary: | summary |