510(k) Report

Devices descending from K812057

13 later devices reach Vance Cystoscopic through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082319Injekt Filiform Injection NeedleCook Urological, Inc.20080—
+1K022484Cook Injection NeedleCook Urological, Inc.200212—
+2K221085LiNA OperaScope NeedleLina Medical Aps20220—
+2K171602Williams Cystoscopic Injection NeedleCook Incorporated201711
+2K113634Injekt Cysto Flexible Injection NeedleCook Ireland, Ltd.20120—
+2K090830Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd.200931
+2K090217Bonee Needle for Bladder Injections, MODELSNBI035, NBI070Coloplast A/S20092—
+3K241523injeTAK Adjustable Tip Needle (DIS199; DIS201)Laborie Medical Technologies, Corp.20240—
+3K192498Single Use InjectorOlympus Medical Systems Corp.20201—
+3K182876Uro-N CystoscopeUroviu Corporation20190—
+3K180214Repris Bladder Injection SystemUro-1, Inc.20181—
+4K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.20260—
+4K250522Multi4 SystemMulti4 Medical AB20250—