Clearance Summary
PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE received FDA 510(k) clearance under submission number K853207, sponsored by American Pharmaseal Div. Ahsc. 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 1985-09-12.
- Submission: K853207
- Applicant / Sponsor: American Pharmaseal Div. Ahsc
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1985-09-12
Classification & Regulation
This clearance is catalogued under FDA product code KOD and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.