Clearance Summary
Sclerotherapy & Endoscopic Needles received FDA 510(k) clearance under submission number K222006, 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 2023-04-03.
- Submission: K222006
- Applicant / Sponsor: G-Flex Europe Sprl
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2023-04-03
Classification & Regulation
This clearance is catalogued under FDA product code FBK and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.