Clearance Summary
ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 received FDA 510(k) clearance under submission number K014002, sponsored by Fortune Medical Instrument Corp.. 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 2002-03-04.
- Submission: K014002
- Applicant / Sponsor: Fortune Medical Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5090
- Decision date: 2002-03-04
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.