Clearance Summary
KARL STORZ TIPCAM1 Rubina received FDA 510(k) clearance under submission number K262547, sponsored by KALR 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 2026-09-21.
- Submission: K262547
- Applicant / Sponsor: KALR STORZ SE & Co. KG
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2026-09-21
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.