Clearance Summary
MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES received FDA 510(k) clearance under submission number K030179, sponsored by Surgical Instruments Service and Savings, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2003-01-24.
- Submission: K030179
- Applicant / Sponsor: Surgical Instruments Service and Savings, Inc.
- Clearance pathway: Abbreviated
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4670
- Decision date: 2003-01-24
Classification & Regulation
This clearance is catalogued under FDA product code NKX and 21 CFR 886.4670, within the Ophthalmic review panel as a Class II device.