Clearance Summary
KARL STORZ Monopolar Resectoscopes with HF Cable received FDA 510(k) clearance under submission number K232486, 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 2024-05-07.
- Submission: K232486
- 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: 2024-05-07
Classification & Regulation
This clearance is catalogued under FDA product code FJL and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.