Clearance Summary
THE INQUINAL RESORVOIR INSERTER received FDA 510(k) clearance under submission number K802983, sponsored by Lone Star Medical Products, Inc.. 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 1980-12-30.
- Submission: K802983
- Applicant / Sponsor: Lone Star Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1980-12-30
Classification & Regulation
This clearance is catalogued under FDA product code KOA and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.