Clearance Summary
Image1 SPIES System received FDA 510(k) clearance under submission number K160044, sponsored by Karl Storz Endoscopy America, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2016-02-01.
- Submission: K160044
- Applicant / Sponsor: Karl Storz Endoscopy America, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2016-02-01
Classification & Regulation
This clearance is catalogued under FDA product code FET and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.