Clearance Summary
OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS received FDA 510(k) clearance under submission number K980465, sponsored by Olympus 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 1998-04-21.
- Submission: K980465
- Applicant / Sponsor: Olympus America, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1998-04-21
Classification & Regulation
This clearance is catalogued under FDA product code FDT and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.