Clearance Summary
VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) received FDA 510(k) clearance under submission number K972100, sponsored by Advanced Care Medical Products. 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 1997-07-31.
- Submission: K972100
- Applicant / Sponsor: Advanced Care Medical Products
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5250
- Decision date: 1997-07-31
Classification & Regulation
This clearance is catalogued under FDA product code EXJ and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class I device.