Clearance Summary
ENDODYNAMIC SIEGEL SPHINCTEROTOME received FDA 510(k) clearance under submission number K853680, sponsored by E-Z-Em, 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 1985-11-04.
- Submission: K853680
- Applicant / Sponsor: E-Z-Em, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 1985-11-04
Classification & Regulation
This clearance is catalogued under FDA product code KNS and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.