Clearance Summary
NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 received FDA 510(k) clearance under submission number K071819, sponsored by Ncontact Surgical, Inc.. 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 2007-07-26.
- Submission: K071819
- Applicant / Sponsor: Ncontact Surgical, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2007-07-26
Classification & Regulation
This clearance is catalogued under FDA product code OCL and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.