Clearance Summary
FUNS-10, FUNS-11 received FDA 510(k) clearance under submission number K862551, sponsored by Reichert-Jung, 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 1986-09-12.
- Submission: K862551
- Applicant / Sponsor: Reichert-Jung, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1986-09-12
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.