Clearance Summary
5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH received FDA 510(k) clearance under submission number K992402, sponsored by Telemed Systems, Inc.. 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 1999-12-22.
- Submission: K992402
- Applicant / Sponsor: Telemed Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 1999-12-22
Classification & Regulation
This clearance is catalogued under FDA product code KNS and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.