510(k) Report

Devices descending from K022484

12 later devices reach Cook Injection Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221085LiNA OperaScope NeedleLina Medical Aps20220—
+1K171602Williams Cystoscopic Injection NeedleCook Incorporated201711
+1K113634Injekt Cysto Flexible Injection NeedleCook Ireland, Ltd.20120—
+1K090830Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd.200931
+1K090217Bonee Needle for Bladder Injections, MODELSNBI035, NBI070Coloplast A/S20092—
+1K082319Injekt Filiform Injection NeedleCook Urological, Inc.20080—
+2K241523injeTAK Adjustable Tip Needle (DIS199; DIS201)Laborie Medical Technologies, Corp.20240—
+2K192498Single Use InjectorOlympus Medical Systems Corp.20201—
+2K182876Uro-N CystoscopeUroviu Corporation20190—
+2K180214Repris Bladder Injection SystemUro-1, Inc.20181—
+3K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.20260—
+3K250522Multi4 SystemMulti4 Medical AB20250—