Clearance Summary
CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE received FDA 510(k) clearance under submission number K031482, sponsored by Cryomedical Instruemts , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2003-07-10.
- Submission: K031482
- Applicant / Sponsor: Cryomedical Instruemts , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4250
- Decision date: 2003-07-10
Classification & Regulation
This clearance is catalogued under FDA product code GXH and 21 CFR 882.4250, within the Neurology review panel as a Class II device.