Clearance Summary
Edi Catheter ENFit received FDA 510(k) clearance under submission number K153688, sponsored by Maquet Critical Care AB. 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 2017-03-02.
- Submission: K153688
- Applicant / Sponsor: Maquet Critical Care AB
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2017-03-02
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.