The following data is part of a premarket notification filed by Illumigyn Ltd. with the FDA for Gynescope System.
| Device ID | K190187 |
| 510k Number | K190187 |
| Device Name: | Gynescope System |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | Illumigyn Ltd. Communication Center Neve Ilan, IL 9085000 |
| Contact | Lior Greenstein |
| Correspondent | Ahava Stein A. Stein Regulatory Affairs Consulting Ltd. 20 Hataas St., Suite 102 Kfar Saba, IL 4442520 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-01 |
| Decision Date | 2019-05-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290018240011 | K190187 | 000 |
| 77290018240013 | K190187 | 000 |
| 67290018240016 | K190187 | 000 |
| 57290018240026 | K190187 | 000 |