510(k) Report

Devices descending from K982890

20 later devices reach Advanced Uroscience Injection Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082319Injekt Filiform Injection NeedleCook Urological, Inc.20080—
+1K051905Uroplasty Rigid Endoscopic NeedleUroplasty, Inc.20053—
+1K042615Carbon Medical Technologies Endoscopic Injection NeedleCarbon Medical Technologies, Inc.20042—
+1K022484Cook Injection NeedleCook Urological, Inc.200212—
+1K990996Genyx Medical Injection NeedleGenyx Medical, Inc.199913—
+2K221085LiNA OperaScope NeedleLina Medical Aps20220—
+2K172227Endoscopic Injection NeedleCarbon Medical Technologies, Inc.20170—
+2K171602Williams Cystoscopic Injection NeedleCook Incorporated201711
+2K133148Biomarc Coaxial NeedleCarbon Medical Technologies, Inc.20140—
+2K113634Injekt Cysto Flexible Injection NeedleCook Ireland, Ltd.20120—
+2K090830Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd.200931
+2K091391Uroplasty Rigid Endoscopic Needle, MRN-518Uroplasty, Inc.20091—
+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—
+3K121337Uroplasty Rigid Endoscpic NeedlesUroplasty, Inc.20120—
+4K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.20260—
+4K250522Multi4 SystemMulti4 Medical AB20250—