Clearance Summary
Entuit PEG, Entuit PEGJ received FDA 510(k) clearance under submission number K213356, sponsored by Wilson-Cook Medical, Inc.. 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 2022-01-20.
- Submission: K213356
- Applicant / Sponsor: Wilson-Cook Medical, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2022-01-20
Classification & Regulation
This clearance is catalogued under FDA product code PIF and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.