Clearance Summary
FROG received FDA 510(k) clearance under submission number K072831, sponsored by Newby-Coombs, LLC. 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 2008-12-12.
- Submission: K072831
- Applicant / Sponsor: Newby-Coombs, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2008-12-12
Classification & Regulation
This clearance is catalogued under FDA product code FPD and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.