Clearance Summary
STERILE FOLEY CATHETER received FDA 510(k) clearance under submission number K890310, sponsored by Kosan Far East Ent. , 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 1989-11-30.
- Submission: K890310
- Applicant / Sponsor: Kosan Far East Ent. , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1989-11-30
Classification & Regulation
This clearance is catalogued under FDA product code EYC and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.