Clearance Summary
LIFE-TECH #'S 1106/1156 UROLABS received FDA 510(k) clearance under submission number K812178, 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 1981-08-13.
- Submission: K812178
- 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: 1981-08-13
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.