Clearance Summary
Werewolf RF20000 Controller, FLOW 50 Wand received FDA 510(k) clearance under submission number K162074, sponsored by ArthroCare Corporation. 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 2016-08-22.
- Submission: K162074
- Applicant / Sponsor: ArthroCare Corporation
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2016-08-22
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.