Clearance Summary
COOPERSURGICAL INFRARED COAGULATOR received FDA 510(k) clearance under submission number K974168, sponsored by Hogan & Hartson. 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 1998-01-23.
- Submission: K974168
- Applicant / Sponsor: Hogan & Hartson
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 1998-01-23
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.