Clearance Summary
FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) received FDA 510(k) clearance under submission number K964892, sponsored by Gynecare Innovation Center. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1997-02-04.
- Submission: K964892
- Applicant / Sponsor: Gynecare Innovation Center
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1997-02-04
Classification & Regulation
This clearance is catalogued under FDA product code FJL and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.