Clearance Summary
PRO PULSE SYRINGE IRRIGATION SYSTEM received FDA 510(k) clearance under submission number K941385, sponsored by Giesy Consultants, 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 1994-06-09.
- Submission: K941385
- Applicant / Sponsor: Giesy Consultants, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1994-06-09
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.