Clearance Summary
Cysto-Gastro-Sets received FDA 510(k) clearance under submission number K211909, sponsored by G-Flex Europe Sprl. 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 2022-06-09.
- Submission: K211909
- Applicant / Sponsor: G-Flex Europe Sprl
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2022-06-09
Classification & Regulation
This clearance is catalogued under FDA product code KNS and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.