Clearance Summary
ZIP CONDOM CATHETER received FDA 510(k) clearance under submission number K964219, sponsored by Goulter Medical, Inc.. 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 1997-08-11.
- Submission: K964219
- Applicant / Sponsor: Goulter Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5250
- Decision date: 1997-08-11
Classification & Regulation
This clearance is catalogued under FDA product code EYZ and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class I device.