Clearance Summary
THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS received FDA 510(k) clearance under submission number K011055, sponsored by Go Medical Industries Pty. , 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 2001-06-06.
- Submission: K011055
- Applicant / Sponsor: Go Medical Industries Pty. , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2001-06-06
Classification & Regulation
This clearance is catalogued under FDA product code FCM and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.