Clearance Summary
REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY POWER CORD, MODEL V5100-00,V5701-00,V5702 received FDA 510(k) clearance under submission number K003624, sponsored by Arthrocare Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2000-12-20.
- Submission: K003624
- Applicant / Sponsor: Arthrocare Corp.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2000-12-20
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.