Clearance Summary
THE PERCUTANEOUS NEPHROSTOLITHOTOMY DRAPE received FDA 510(k) clearance under submission number K851675, sponsored by Lingeman Medical Products, 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 1985-05-14.
- Submission: K851675
- Applicant / Sponsor: Lingeman Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 1985-05-14
Classification & Regulation
This clearance is catalogued under FDA product code EYY and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.