Clearance Summary
KARL STORZ ICG Imaging System received FDA 510(k) clearance under submission number K202925, sponsored by Karl Storz Endoscopy_America, 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 2020-12-17.
- Submission: K202925
- Applicant / Sponsor: Karl Storz Endoscopy_America, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2020-12-17
Classification & Regulation
This clearance is catalogued under FDA product code OWN and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.