Clearance Summary
COAXIAL ELECTRODE #300A received FDA 510(k) clearance under submission number K832566, sponsored by K-Med, 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 1983-11-28.
- Submission: K832566
- Applicant / Sponsor: K-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4480
- Decision date: 1983-11-28
Classification & Regulation
This clearance is catalogued under FDA product code FFK and 21 CFR 876.4480, within the Gastroenterology, Urology review panel as a Class II device.