Clearance Summary
SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE received FDA 510(k) clearance under submission number K053436, sponsored by Cryocath Technologies, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2006-01-13.
- Submission: K053436
- Applicant / Sponsor: Cryocath Technologies, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2006-01-13
Classification & Regulation
This clearance is catalogued under FDA product code OCL and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.