Clearance Summary
KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) received FDA 510(k) clearance under submission number K243550, 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 2025-06-06.
- Submission: K243550
- 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: 2025-06-06
Classification & Regulation
This clearance is catalogued under FDA product code FGB and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.