Clearance Summary
KOLLMANN URETHRAL DILATOR received FDA 510(k) clearance under submission number K841386, sponsored by Imm Enterprises , Ltd.. 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 1984-05-09.
- Submission: K841386
- Applicant / Sponsor: Imm Enterprises , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5520
- Decision date: 1984-05-09
Classification & Regulation
This clearance is catalogued under FDA product code KOE and 21 CFR 876.5520, within the Gastroenterology, Urology review panel as a Class II device.