Clearance Summary
MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE received FDA 510(k) clearance under submission number K972926, 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 1997-10-08.
- Submission: K972926
- Applicant / Sponsor: KARL STORZ Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1997-10-08
Classification & Regulation
This clearance is catalogued under FDA product code FBN and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.