Clearance Summary
CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER received FDA 510(k) clearance under submission number K112093, sponsored by Keeler Instruments, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2011-12-08.
- Submission: K112093
- Applicant / Sponsor: Keeler Instruments, Inc.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4170
- Decision date: 2011-12-08
Classification & Regulation
This clearance is catalogued under FDA product code HRN and 21 CFR 886.4170, within the Ophthalmic review panel as a Class II device.