Clearance Summary
KARL STORZ Endoscopic Accessories for Urology received FDA 510(k) clearance under submission number K252800, sponsored by Karl Storz SE & CO. KG. 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 2026-06-03.
- Submission: K252800
- Applicant / Sponsor: Karl Storz SE & CO. KG
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2026-06-03
Classification & Regulation
This clearance is catalogued under FDA product code OCZ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.