Clearance Summary
URO-MALE INCONTINENCE CATHETER received FDA 510(k) clearance under submission number K841224, sponsored by Gil-Med Industries C/O Kegan & Kegan, 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 1984-05-02.
- Submission: K841224
- Applicant / Sponsor: Gil-Med Industries C/O Kegan & Kegan, Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5250
- Decision date: 1984-05-02
Classification & Regulation
This clearance is catalogued under FDA product code KNX and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class II device.