Clearance Summary
VITRUVIAN INFILTRATION PUMP received FDA 510(k) clearance under submission number K170629, sponsored by Black & Black Surgical, Inc.. 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 2017-06-22.
- Submission: K170629
- Applicant / Sponsor: Black & Black Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5040
- Decision date: 2017-06-22
Classification & Regulation
This clearance is catalogued under FDA product code QPB and 21 CFR 878.5040, within the General, Plastic Surgery review panel as a Class II device.