Clearance Summary
ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER received FDA 510(k) clearance under submission number K980919, 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 1998-03-31.
- Submission: K980919
- Applicant / Sponsor: Fortune Medical Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1998-03-31
Classification & Regulation
This clearance is catalogued under FDA product code EZL and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.