Clearance Summary
U-TEX received FDA 510(k) clearance under submission number K955810, sponsored by Laborie Medical Technologies, 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 1996-01-24.
- Submission: K955810
- Applicant / Sponsor: Laborie Medical Technologies, Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5160
- Decision date: 1996-01-24
Classification & Regulation
This clearance is catalogued under FDA product code FHA and 21 CFR 876.5160, within the Gastroenterology, Urology review panel as a Class I device.