Clearance Summary
KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES received FDA 510(k) clearance under submission number K062659, sponsored by Kirwan Surgical Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2007-03-09.
- Submission: K062659
- Applicant / Sponsor: Kirwan Surgical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4115
- Decision date: 2007-03-09
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.