Clearance Summary
PERCUTANEOUS NEPHROSTOMY SET received FDA 510(k) clearance under submission number K820867, sponsored by Van-Tec, 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 1982-04-13.
- Submission: K820867
- Applicant / Sponsor: Van-Tec, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1982-04-13
Classification & Regulation
This clearance is catalogued under FDA product code GBO and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.