Clearance Summary
IRRIGATION SETS received FDA 510(k) clearance under submission number K023808, sponsored by International Medsurg Connection. 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 2003-03-10.
- Submission: K023808
- Applicant / Sponsor: International Medsurg Connection
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2003-03-10
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.