Clearance Summary
MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000 received FDA 510(k) clearance under submission number K052861, sponsored by Sanarus Medical, 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 2005-11-15.
- Submission: K052861
- Applicant / Sponsor: Sanarus Medical, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4350
- Decision date: 2005-11-15
Classification & Regulation
This clearance is catalogued under FDA product code GEH and 21 CFR 878.4350, within the General, Plastic Surgery review panel as a Class II device.