Clearance Summary
FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 received FDA 510(k) clearance under submission number K061865, sponsored by Guidant 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 2006-07-27.
- Submission: K061865
- Applicant / Sponsor: Guidant Corp.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2006-07-27
Classification & Regulation
This clearance is catalogued under FDA product code NEY and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.