Clearance Summary
LUBRICANO STERILE GEL received FDA 510(k) clearance under submission number K081990, sponsored by Farco Pharma GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2008-12-05.
- Submission: K081990
- Applicant / Sponsor: Farco Pharma GmbH
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2008-12-05
Classification & Regulation
This clearance is catalogued under FDA product code FHX and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.