Gynecare Innovation Center
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K980393 | SOPRANO CRYO-THERAPY SYSTEM | May 1, 1998 |
| K971305 | FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM | August 11, 1997 |
| K964441 | FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA) | March 28, 1997 |
| K964892 | FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) | February 4, 1997 |
| K963872 | FEMRX MORCELLATOR SYSTEM | January 17, 1997 |
| K962506 | [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] | September 16, 1996 |
| K954775 | FLO-STAT FLUID MONITORING SYSTEM | May 10, 1996 |
| K954648 | FEMRX OPERASTAR SYSTEM | March 14, 1996 |