Clearance Summary
ADD-A-CATH received FDA 510(k) clearance under submission number K884061, sponsored by Femcare , 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 1988-10-25.
- Submission: K884061
- Applicant / Sponsor: Femcare , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5090
- Decision date: 1988-10-25
Classification & Regulation
This clearance is catalogued under FDA product code KOB and 21 CFR 876.5090, within the Gastroenterology, Urology review panel as a Class II device.