The following data is part of a premarket notification filed by Gynecare Innovation Center with the FDA for Femrx Operastar System.
| Device ID | K954648 |
| 510k Number | K954648 |
| Device Name: | FEMRX OPERASTAR SYSTEM |
| Classification | Hysteroscope (and Accessories) |
| Applicant | GYNECARE INNOVATION CENTER 1221 INNSBRUCK DR. Sunnyvale, CA 94089 |
| Contact | Michael A Daniel |
| Correspondent | Michael A Daniel GYNECARE INNOVATION CENTER 1221 INNSBRUCK DR. Sunnyvale, CA 94089 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-10 |
| Decision Date | 1996-03-14 |