Clearance Summary
UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES received FDA 510(k) clearance under submission number K993721, sponsored by Laborie Medical Tech Corp.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1999-11-29.
- Submission: K993721
- Applicant / Sponsor: Laborie Medical Tech Corp.
- Clearance pathway: Abbreviated
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5320
- Decision date: 1999-11-29
Classification & Regulation
This clearance is catalogued under FDA product code KPI and 21 CFR 876.5320, within the Gastroenterology, Urology review panel as a Class II device.