Clearance Summary
STIMTECH PFX, CATALOG NUMBER 78-8540 received FDA 510(k) clearance under submission number K922562, sponsored by Stimtech Products. 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 1993-10-13.
- Submission: K922562
- Applicant / Sponsor: Stimtech Products
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5320
- Decision date: 1993-10-13
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.