Clearance Summary
DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE received FDA 510(k) clearance under submission number K945171, sponsored by Boston 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 1995-02-08.
- Submission: K945171
- Applicant / Sponsor: Boston Surgical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4360
- Decision date: 1995-02-08
Classification & Regulation
This clearance is catalogued under FDA product code KYG and 21 CFR 886.4360, within the Ophthalmic review panel as a Class I device.