Clearance Summary
SUMO ACCESS AND TISSUE RESECTION SYSTEM received FDA 510(k) clearance under submission number K103155, sponsored by Apollo Endosurgery, Inc.. 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 2011-10-28.
- Submission: K103155
- Applicant / Sponsor: Apollo Endosurgery, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2011-10-28
Classification & Regulation
This clearance is catalogued under FDA product code ODC and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.