Clearance Summary
MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS received FDA 510(k) clearance under submission number K883189, sponsored by KARL STORZ Endoscopy-America, 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 1989-02-13.
- Submission: K883189
- Applicant / Sponsor: KARL STORZ Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4480
- Decision date: 1989-02-13
Classification & Regulation
This clearance is catalogued under FDA product code FFK and 21 CFR 876.4480, within the Gastroenterology, Urology review panel as a Class II device.