Clearance Summary
VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT received FDA 510(k) clearance under submission number K111881, sponsored by Coloplast A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2011-08-17.
- Submission: K111881
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2011-08-17
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.