Clearance Summary
STERILE FLUID PRODUCING UNIT #EP550 received FDA 510(k) clearance under submission number K832040, sponsored by American Cystocope Makers, 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 1983-09-29.
- Submission: K832040
- Applicant / Sponsor: American Cystocope Makers, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1983-09-29
Classification & Regulation
This clearance is catalogued under FDA product code LJH and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.