Clearance Summary
ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 received FDA 510(k) clearance under submission number K090583, 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 2009-06-26.
- Submission: K090583
- Applicant / Sponsor: Apollo Endosurgery, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2009-06-26
Classification & Regulation
This clearance is catalogued under FDA product code KGE and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.