Clearance Summary
CATHETER, URETHRAL PRESSURE, UPE-10 & 12 received FDA 510(k) clearance under submission number K770579, sponsored by Life-Tech Instruments, 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 1977-05-23.
- Submission: K770579
- Applicant / Sponsor: Life-Tech Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1620
- Decision date: 1977-05-23
Classification & Regulation
This clearance is catalogued under FDA product code FAP and 21 CFR 876.1620, within the Gastroenterology, Urology review panel as a Class II device.