The following data is part of a premarket notification filed by Gynecare Innovation Center with the FDA for Femrx Turp Sr System (ts27xx-yy/ts24xx-yy).
| Device ID | K964892 |
| 510k Number | K964892 |
| Device Name: | FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) |
| Classification | Resectoscope |
| Applicant | GYNECARE INNOVATION CENTER 1221 INNSBRUCK DR. Sunnyvale, CA 94089 |
| Contact | John N Zorich |
| Correspondent | John N Zorich GYNECARE INNOVATION CENTER 1221 INNSBRUCK DR. Sunnyvale, CA 94089 |
| Product Code | FJL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-06 |
| Decision Date | 1997-02-04 |
| Summary: | summary |