Clearance Summary
LABORIE URODYNAMICS PROCESSOR received FDA 510(k) clearance under submission number K920777, sponsored by R. Laborie Surgical , 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 1992-09-04.
- Submission: K920777
- Applicant / Sponsor: R. Laborie Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1620
- Decision date: 1992-09-04
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.