Clearance Summary
VARIOUS SURGICAL OR PATIENT DRAPES received FDA 510(k) clearance under submission number K980210, sponsored by Gel-Lite, LLC. 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 1998-05-15.
- Submission: K980210
- Applicant / Sponsor: Gel-Lite, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 1998-05-15
Classification & Regulation
This clearance is catalogued under FDA product code KKX and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.