Clearance Summary
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 received FDA 510(k) clearance under submission number K101297, sponsored by Coloplast A/S. 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 2010-06-03.
- Submission: K101297
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2010-06-03
Classification & Regulation
This clearance is catalogued under FDA product code OTM and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.