Clearance Summary
URETERAL CATHETER AND ACCESSORIES received FDA 510(k) clearance under submission number K934419, sponsored by Urological Associates of Central Jersey P.A.. 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 1994-05-25.
- Submission: K934419
- Applicant / Sponsor: Urological Associates of Central Jersey P.A.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5130
- Decision date: 1994-05-25
Classification & Regulation
This clearance is catalogued under FDA product code EYK and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class I device.