Clearance Summary
FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU received FDA 510(k) clearance under submission number K964441, sponsored by Gynecare Innovation Center. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1997-03-28.
- Submission: K964441
- Applicant / Sponsor: Gynecare Innovation Center
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4160
- Decision date: 1997-03-28
Classification & Regulation
This clearance is catalogued under FDA product code KNF and 21 CFR 884.4160, within the Obstetrics/Gynecology review panel as a Class II device.