The following data is part of a premarket notification filed by Gynecare Innovation Center with the FDA for Femrx Focused Monopolar (fap) Operastar System [outpatient Endoscopic Resection And Ablation (opera)] [specialized Tissu.
| Device ID | K964441 |
| 510k Number | K964441 |
| Device Name: | FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (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 | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-06 |
| Decision Date | 1997-03-28 |
| Summary: | summary |