Clearance Summary
NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO received FDA 510(k) clearance under submission number K925161, sponsored by North American Sterilization & Packaging Co.. 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 1993-07-21.
- Submission: K925161
- Applicant / Sponsor: North American Sterilization & Packaging Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1993-07-21
Classification & Regulation
This clearance is catalogued under FDA product code KNY and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.