Clearance Summary
KIRWAN IRRIGATION/ASPIRATION HANDPIECE received FDA 510(k) clearance under submission number K930113, 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 1994-02-17.
- Submission: K930113
- Applicant / Sponsor: Kirwan Surgical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1994-02-17
Classification & Regulation
This clearance is catalogued under FDA product code HMX and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.