510(k) Report

Devices descending from K981615

2 later devices reach Ksea Uropump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162992Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc.20171—
+2K213334Monarch Platform, UrologyAuris Health, Inc.202201