FDA 510(k) Applications for Medical Device Product Code "NUJ"
(Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed)

FDA 510(k) Number Applicant Device Name Decision Date
K012603 ALLIANCE MEDICAL CORP. REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS 11/07/2001
K110189 ASCENT HEALTHCARE SOLUTIONS REPROCESSED ELECTROSURGICAL INSTRUMENT 07/18/2011
K111600 ASCENT HEALTHCARE SOLUTIONS REPROCESSED HAND ACTIVATE SEALER/DIVIDER 11/15/2011
K131614 COVIDIEN REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM 08/29/2013
K211203 Green OR, LLC. Green OR Reprocessed Aquamantys Bipolar Sealer 04/07/2022
K090661 Northeast Scientific, Inc. NES REPROCESSED VARICOSE VEIN RF CATHETER 07/21/2010
K173214 Northeast Scientific, Inc. (NES) NES Reprocessed RF Stylet (RFS) 03/27/2018
K173741 ReNovo, Inc. Reprocessed ArthoCare Ablation Wand 03/05/2018
K172647 ReNovo, Inc. Reprocessed ArthroCare ENT Coblator 02/21/2018
K173740 ReNovo, Inc. Reprocessed DePuy Mitek Ablation Wand 03/19/2018
K143260 STERILMED, INC. Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider 02/23/2015
K161086 Sterilmed, Inc. Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) 09/20/2016
K012598 STERILMED, INC. REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS 11/07/2001
K073613 STERILMED, INC. REPROCESSED SCISSOR TIPS 02/12/2008
K120040 STERILMED, INC. REPROCESSED SURGICAL ELECTRIC INSTRUMENT 10/05/2012
K123096 STERILMED, INC. REPROCESSED VESSEL SEALER 01/25/2013
K152134 STERILMED, INC. Reprocessed Vessel Sealer 01/15/2016
K133578 STRYKER SUSTAINABILITY SOLUTIONS REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER 04/10/2014
K220411 Stryker Sustainability Solutions Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) 05/13/2022
K230251 Stryker Sustainability Solutions Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) 03/28/2023
K180451 Stryker Sustainability Solutions Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider 04/20/2018
K150538 STRYKER SUSTAINABILITY SOLUTIONS Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider 06/25/2015
K180499 Stryker Sustainability Solutions Reprocessed LigaSure Maryland Jaw Sealer/Divider 04/23/2018
K121855 STRYKER SUSTAINABILITY SOLUTIONS RESPROCESSED SERFAS ENERGY PROBE 08/16/2012
K052695 SURETEK MEDICAL SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS 05/10/2006
K052692 SURETEK MEDICAL SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES 05/10/2006
K052690 SURETEK MEDICAL SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS 05/12/2006
K171324 Surgical Instrument Service and Savings Inc Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics 06/23/2017
K160333 SURGICAL INSTRUMENT SERVICE AND SAVINGS INC Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider 07/20/2016
K172608 Surgical Instrument Service and Savings Inc Medline ReNewal Reprocessed Stryker SERF AS Energy Probes 10/18/2017
K153745 SURGICAL INSTRUMENT SERVICE AND SAVINGS INC (DBA MEDLINE REN Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider 05/02/2016
K182588 Surgical Instrument Service and Savings Inc (dba Medline ReN Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider 10/31/2018
K152313 Surgical Instrument Services and Savings, Inc Medline ReNewal Reprocessed Endopath Endoscopic Instruments 01/06/2016
K162751 Surgical Instrument Services and Savings, Inc Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider 05/01/2017
K043198 VANGUARD MEDICAL CONCEPTS, INC. VANGUARD REPROCESSED ARTHROSCOPIC WANDS 05/27/2005
K191073 Vein360, LLC Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter 10/22/2019


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