510(k) Report

Devices descending from K954465

46 later devices reach FMS Duo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152278ENDOFLOW II - Irrigation, Warming and Suction SystemPromepla Sam20160—
+1K132883Hemodia Arthroscopy Pump Tube Sets (Hats)Hemodia Sas20130—
+1K1311914MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM Barrel Tornado Bur Plus…Depuy Mitek, A Johnson & Johnson Company20130—
+1K130912Omnicut Resection BladeDepuy Mitek, A Johnson & Johnson Company20130—
+1K130169FMS Vue Fluid Managment System, FMS Connect Interface CableDepuy Mitek, A Johnson & Johnson Company20135—
+1K093471Karl Storz Arthropump Power Irrigation/Suction PumpKARL STORZ Endoscopy-America, Inc.20100—
+1K093409Powerpump Arthroscopy SystemMedical Vision AB201001
+1K083707Arthrex Dual Wave Arthroscopy Fluid Management DeviceArthrex, Inc.20093—
+1K080122Sopro 670 Arthroscopic PumpSopro20080—
+1K063326Conmed Linvatec 24K Irrigation SystemConmed Linvatec20071—
+1K041824X-Treme Arthroscopic Pump and Shaver SystemFuture Medical Systems, SA200562
+1K030402Arthroscopy Pump, Model A107W.O.M. World of Medicine AG200329—
+2K233675FMS VUE™ Fluid Management and Tissue Debridement SystemDePuy Mitek, Inc.20240—
+2K192921Zeos Aqua Vision Pump and tubeHemodia Sas20202—
+2K182882CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote ControlConmed Corporation20180—
+2K180735Endomat SelectKarl Storz SE & CO. KG20182—
+2K173311ARTHRO-Pump PA304W.O.M. World of Medicine GmbH20180—
+2K171237FMS VUE II Fluid Management and Tissue Debridement SystemMedos International SARL20180—
+2K123441Stryker Crossflow Arthroscopy PumpStryker Endoscopy20135—
+2K062380Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG2006151
+2K060172Rema Shaver BladesRema Medizintechnik GmbH.20060—
+2K050580Smith & Nephew Intelijet Fluid Management SystemsSmith & Nephew Endoscopy, Inc.20052—
+2K033927Arthoscopy Pump A115W.O.M. World of Medicine AG20043—
+3K250795Purevue™ FMSW.O.M. World of Medicine GmbH20250—
+3K203480DOUBLEFLO systemHemodia Sas20211—
+3K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG20201—
+3K191259Stryker CrossFlow Integrated Arthroscopy PumpStryker Corp.20190—
+3K162770Relign SystemRelign Corporation20172—
+3K112642Aquilex Fluid Control System H112W.O.M. World of Medicine AG201214—
+3K051326Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc.200516
+4K261706Endomat Select (UP220)Karl Storz SE & CO. KG20260—
+4K241008Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece…Relign Corporation, Subsidiary of Zimmer Biomet20240—
+4K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece…Relign Corporation20231—
+4K221919DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing setsHemodia Sas20230—
+4K180825Fluent Fluid Management SystemHologic, Inc.20182—
+4K173489GYN-Pump PH304W.O.M. World of Medicine GmbH201801
+4K172040Aquilex Fluid Control System AQL-100SW.O.M. World of Medicine GmbH201802
+4K171794Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc.20170—
+4K123732Hysteroscopy Pump HM6W.O.M. World of Medicine AG20136—
+5K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…Hologic, Inc.20240—
+5K233710Symphion Operative Hysteroscopy SystemMinerva Surgical, Inc.20240—
+5K190372Aveta SystemMeditrina, Inc.20194—
+6K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable…Meditrina, Inc.20221—
+6K192100Aveta Disposable HysteroscopeMeditrina, Inc.20190—
+6K191958Aveta SystemMeditrina, Inc.20190—
+7K223813Aveta System 2.0Meditrina, Inc.20230—