Clearance Summary
endomina system received FDA 510(k) clearance under submission number K211309, sponsored by Endo Tools Therapeutics S.A.. 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 2021-12-07.
- Submission: K211309
- Applicant / Sponsor: Endo Tools Therapeutics S.A.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2021-12-07
Classification & Regulation
This clearance is catalogued under FDA product code OCW and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.