Clearance Summary
ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP received FDA 510(k) clearance under submission number K970526, sponsored by Arthrocare Corp.. 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 1997-05-28.
- Submission: K970526
- Applicant / Sponsor: Arthrocare Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 1997-05-28
Classification & Regulation
This clearance is catalogued under FDA product code FAS and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.