Clearance Summary
K-KATH URETHRAL CATHETER INTRODUCER received FDA 510(k) clearance under submission number K802878, sponsored by B&K Medical. 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 1981-01-02.
- Submission: K802878
- Applicant / Sponsor: B&K Medical
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1981-01-02
Classification & Regulation
This clearance is catalogued under FDA product code KOD and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.