Clearance Summary
LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP received FDA 510(k) clearance under submission number K945761, sponsored by Aaron Medical Industries. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1995-04-10.
- Submission: K945761
- Applicant / Sponsor: Aaron Medical Industries
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4115
- Decision date: 1995-04-10
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.