Clearance Summary
Standard Bougie, 38 Fr. and Hand Pump received FDA 510(k) clearance under submission number K212728, sponsored by Standard Bariatrics. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2021-09-23.
- Submission: K212728
- Applicant / Sponsor: Standard Bariatrics
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2021-09-23
Classification & Regulation
This clearance is catalogued under FDA product code KNT and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.