Clearance Summary
F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY received FDA 510(k) clearance under submission number K083428, sponsored by Fiab Spa. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2009-09-01.
- Submission: K083428
- Applicant / Sponsor: Fiab Spa
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4115
- Decision date: 2009-09-01
Classification & Regulation
This clearance is catalogued under FDA product code HQP and 21 CFR 886.4115, within the Ophthalmic review panel as a Class II device.