Clearance Summary
URODYNAMICS TUBING AND INFUSION SETS received FDA 510(k) clearance under submission number K954341, sponsored by Life-Tech Intl., Inc.. 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 1995-10-17.
- Submission: K954341
- Applicant / Sponsor: Life-Tech Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1620
- Decision date: 1995-10-17
Classification & Regulation
This clearance is catalogued under FDA product code FEN and 21 CFR 876.1620, within the Gastroenterology, Urology review panel as a Class II device.