Clearance Summary
Gastric Alimetry System received FDA 510(k) clearance under submission number K213924, sponsored by Alimetry , Ltd.. 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 2022-06-03.
- Submission: K213924
- Applicant / Sponsor: Alimetry , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1735
- Decision date: 2022-06-03
Classification & Regulation
This clearance is catalogued under FDA product code MYE and 21 CFR 876.1735, within the Gastroenterology, Urology review panel as a Class II device.