FDA 510(k) Applications Submitted by Covidien LLC

FDA 510(k) Number Submission Date Device Name Applicant
K120773 03/14/2012 NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM Covidien LLC
K152794 09/28/2015 Cytosponge Cell Collection Device Covidien LLC
K120863 03/22/2012 WHOLEY GUIDE WIRE SYSTEM Covidien LLC
K133762 12/11/2013 ENDO GIA(TM) EXTRA LONG ADAPTER Covidien LLC
K143654 12/23/2014 Valleylab LS10 Generator COVIDIEN LLC
K123066 10/01/2012 ACCUMESH DEPLOYMENT SYSTEM Covidien LLC
K151163 05/01/2015 Signia Loading Unit, Tri-Staple 2.0 Cartridge Covidien LLC
K163654 12/23/2016 VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar Covidien llc
K142048 07/28/2014 EMPRINT PROCEDURE PLANNING APPLICATION Covidien LLC
K133821 12/16/2013 EMPRINT ABLATION SYSTEM Covidien LLC
K120605 02/28/2012 PERMACOL SURGICAL IMPLANT Covidien LLC
K121139 04/16/2012 ACCUMESH DEPLOYMENT SYSTEM Covidien LLC
K103052 10/14/2010 V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE Covidien LLC
K151376 05/22/2015 superDimension Navigation System Covidien LLC
K142839 09/30/2014 GenCut Core Biopsy System Covidien LLC
K130782 03/21/2013 ACCUMESH DEPLOYMENT SYSTEM Covidien LLC
K132493 08/09/2013 ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY Covidien LLC
K130357 02/13/2013 SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH Covidien LLC
K173244 10/06/2017 superDimension Navigation System V7.2 Covidien LLC
K163537 12/16/2016 Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga Covidien llc
K151659 06/19/2015 ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks Covidien LLC
K142865 09/30/2014 Nellcor Bedside SpO2 Patient Monitoring System Covidien LLC
K102737 09/22/2010 KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER Covidien LLC
K141542 06/10/2014 NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS ) Covidien LLC
K143091 10/28/2014 Surgisleeve Wound Protector Covidien LLC
K160290 02/03/2016 Valleylab REM Polyhesive Infant Patient Return Electrode Covidien LLC
K153371 11/23/2015 Sonicision Cordless Ultrasonic Dissection Device COVIDIEN LLC
K163105 11/07/2016 Emprint Ablation System COVIDIEN LLC
K180037 01/05/2018 Beacon EUS Access System Covidien llc
K150251 02/03/2015 Barrx Anorectal RFA Wand Covidien LLC
K181020 04/17/2018 Cytosponge Cell Collection Device Covidien llc
K142364 08/25/2014 Barrx RFA Self Sizing Balloon Catheter Covidien llc
K152586 09/10/2015 Beacon Fine Needle Fiducial System Covidien LLC
K162802 10/05/2016 Barrx Anorectal RFA Wand COVIDIEN LLC
K163098 11/07/2016 Tri-Staple 2.0 Intelligent Cartridge Covidien LLC
K160654 03/08/2016 GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) Covidien LLC
K151356 05/20/2015 Spacemaker Pro Access and Dissector System Covidien LLC
K143598 12/18/2014 Lapro-Clip Auto Suture Reusable Long Clip Applier Covidien LLC
K130623 03/08/2013 BARRX CHANNEL RFA ENDOSCOPIC CATHETER Covidien LLC
K142695 09/22/2014 Cytosponge Cell Collection Device Covidien LLC
K142654 09/18/2014 Fortrex 0.035 OTW PTA Balloon Catheter Covidien LLC
K142198 08/11/2014 BNX Fine Needle Aspiration System Covidien LLC
K173559 11/17/2017 Barrx SB RFA Endoscopic Catheter Covidien llc
K182868 10/12/2018 INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor Covidien llc
K170170 01/19/2017 Valleylab FT10 Electrosurgical Platform Covidien llc
K172757 09/13/2017 Valleylab FX8 Electrosurgical Platform Covidien llc
K160360 02/09/2016 Barrx FLEX RFA Energy Generator Covidien llc


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact