Clearance Summary
DiLumen C2 and Tool Mount received FDA 510(k) clearance under submission number K211819, sponsored by Lumendi, 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 2021-10-22.
- Submission: K211819
- Applicant / Sponsor: Lumendi, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2021-10-22
Classification & Regulation
This clearance is catalogued under FDA product code FDF and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.