Clearance Summary
ULTRASHARP CONCENTRIC NEEDLES received FDA 510(k) clearance under submission number K080914, sponsored by Rochester Electro Medical, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2008-07-15.
- Submission: K080914
- Applicant / Sponsor: Rochester Electro Medical, Inc.
- Clearance pathway: Abbreviated
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1385
- Decision date: 2008-07-15
Classification & Regulation
This clearance is catalogued under FDA product code IKT and 21 CFR 890.1385, within the Physical Medicine review panel as a Class II device.