Clearance Summary
KSEA UROPUMP received FDA 510(k) clearance under submission number K981615, sponsored by KARL STORZ Endoscopy-America, 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 1998-07-08.
- Submission: K981615
- Applicant / Sponsor: KARL STORZ Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1998-07-08
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.