510(k) Report

Devices descending from K843719

24 later devices reach Single Wall Introducer Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040029Safetynet Guidewire IntroducerInjectimed, Inc.20041—
+1K030451Carbon Medical Technologies Injection NeedleCarbon Medical Technologies, Inc.20030—
+1K982890Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc.199820—
+2K082319Injekt Filiform Injection NeedleCook Urological, Inc.20080—
+2K073664Frontline Medical Safetynet Guidewire IntroducerInjectimed, Inc.20080—
+2K051905Uroplasty Rigid Endoscopic NeedleUroplasty, Inc.20053—
+2K042615Carbon Medical Technologies Endoscopic Injection NeedleCarbon Medical Technologies, Inc.20042—
+2K022484Cook Injection NeedleCook Urological, Inc.200212—
+2K990996Genyx Medical Injection NeedleGenyx Medical, Inc.199913—
+3K221085LiNA OperaScope NeedleLina Medical Aps20220—
+3K172227Endoscopic Injection NeedleCarbon Medical Technologies, Inc.20170—
+3K171602Williams Cystoscopic Injection NeedleCook Incorporated201711
+3K133148Biomarc Coaxial NeedleCarbon Medical Technologies, Inc.20140—
+3K113634Injekt Cysto Flexible Injection NeedleCook Ireland, Ltd.20120—
+3K090830Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd.200931
+3K091391Uroplasty Rigid Endoscopic Needle, MRN-518Uroplasty, Inc.20091—
+3K090217Bonee Needle for Bladder Injections, MODELSNBI035, NBI070Coloplast A/S20092—
+4K241523injeTAK Adjustable Tip Needle (DIS199; DIS201)Laborie Medical Technologies, Corp.20240—
+4K192498Single Use InjectorOlympus Medical Systems Corp.20201—
+4K182876Uro-N CystoscopeUroviu Corporation20190—
+4K180214Repris Bladder Injection SystemUro-1, Inc.20181—
+4K121337Uroplasty Rigid Endoscpic NeedlesUroplasty, Inc.20120—
+5K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.20260—
+5K250522Multi4 SystemMulti4 Medical AB20250—