Gynecare Innovation Center
Country not established
- Devices
- 8
What Gynecare Innovation Center makes
Gynecare Innovation Center manufactures specialized medical devices for gynecological procedures, including the FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM for outpatient endoscopic resection and ablation, the SOPRANO CRYO-THERAPY SYSTEM for cryotherapy treatments, the FEMRX MORCELLATOR SYSTEM for tissue removal, the FLO-STAT FLUID MONITORING SYSTEM for fluid management, the FEMRX TURP SR SYSTEM for transurethral resection, and the FEMRX OPERASTAR SYSTEM for specialized tissue aspiration.
The company's devices are classified as Class II and are listed in the FDA 510(k) registry. Gynecare Innovation Center is based in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Soprano Cryo-Therapy System Ref K980393
Regimes: 510(k) Registry: 510(k)Femrx Morcellator System Ref K963872
Regimes: 510(k) Registry: 510(k)Flo-Stat Fluid Monitoring System Ref K954775
Regimes: 510(k) Registry: 510(k)Femrx Turp Sr System (TS27XX-Yy/TS24XX-Yy) Ref K964892
Regimes: 510(k) Registry: 510(k)Femrx Focused Monopolar (Fmp) Opera Star System Ref K971305
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Femrx Operastar System Ref K954648
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gynecare Innovation Center have in the registry?
The registry currently lists 8 devices for Gynecare Innovation Center. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gynecare Innovation Center's devices?
Among its 8 most recently registered devices, Gynecare Innovation Center has devices listed in FDA 510(k) (8 devices).
What risk classes do Gynecare Innovation Center's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Gynecare Innovation Center's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gynecare Innovation Center in the registry?
The most recently registered devices listed for Gynecare Innovation Center include FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU, SOPRANO CRYO-THERAPY SYSTEM, FEMRX MORCELLATOR SYSTEM and FLO-STAT FLUID MONITORING SYSTEM.