Clearance Summary
KARL STORZ 3D VIDEO SYSTEM received FDA 510(k) clearance under submission number K001362, sponsored by Karl Storz Imaging, 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 2000-07-17.
- Submission: K001362
- Applicant / Sponsor: Karl Storz Imaging, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2000-07-17
Classification & Regulation
This clearance is catalogued under FDA product code GCI and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.