Clearance Summary
LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER received FDA 510(k) clearance under submission number K043241, sponsored by Astra Tech, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2004-12-23.
- Submission: K043241
- Applicant / Sponsor: Astra Tech, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2004-12-23
Classification & Regulation
This clearance is catalogued under FDA product code GBM and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.