Clearance Summary
O'NEIL URINARY CATHETER INTRODUCER received FDA 510(k) clearance under submission number K854443, sponsored by Pennine Medical , 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 1986-01-08.
- Submission: K854443
- Applicant / Sponsor: Pennine Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1986-01-08
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.