FDA 510(k) Applications for Medical Device Product Code "PIF"

FDA 510(k) Number Applicant Device Name Decision Date
K222773 Anhui Tiankang Medical Technology Co., Ltd. Feeding Tube 08/17/2023
K142989 APPLIED MEDICAL TECHNOLOGY, INC. Mini ONE Enteral Extension Set 01/29/2015
K150679 BOSTON SCIENTIFIC CORP. EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector 05/29/2015
K161003 BOSTON SCIENTIFIC CORPORATION EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Fee 06/17/2016
K213258 Cair Lgl Nasogastric Feeding Tubes - ENFit Port - PVC 06/09/2022
K210598 CAIR LGL Pediatric Nasogastric Feeding Tubes - Single ENFit Port 11/02/2021
K190923 Cardinal Health Salem Sump Dual Lumen Stomach Tube with ENFit Connection 11/07/2019
K213174 Cardinal Health Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection 05/19/2022
K181787 Cedic S.r.l. Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes 04/25/2019
K190327 Cedic S.r.l. ENConnect 40 mm Screw Cap to ENPlus Adapter 04/09/2019
K181276 Conod Medical Co., Limited CONOD Enteral Feeding Sets 07/12/2018
K142012 CORPAK MEDSYSTEMS FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS 11/20/2014
K150084 COVIDIEN Argyle┐ Polyvinyl Chloride (PVC) and Kangaroo┐ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector 07/13/2015
K143018 Covidien Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors 04/02/2015
K150711 COVIDIEN Salem Sump Dual Lumen Stomach Tube with Multi-functional Port 10/08/2015
K141753 DEGANIA SILICONE, LTD. AQUARIUS NASAL FEEDING TUBE 10/16/2014
K151503 GBUK Enteral Limited NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE 04/05/2016
K203633 GBUK Group Ltd Enteral Extension Sets 08/19/2021
K210854 KB Medical (Group) Inc. Enteral Feeding Set 11/16/2021
K153688 MAQUET CRITICAL CARE AB Edi Catheter ENFit 03/02/2017
K160642 Medline Industries, Inc. Medline ENFit Syringe 11/29/2016
K150286 MEDLINE INDUSTRIES, INC. Medline Enteral Feeding Sets 04/27/2015
K191759 Medline Industries, Inc. Medline Quick Switch Valve with ENFit Connector 12/04/2019
K190414 Moss Tubes, Inc. Moss Gastrostomy Tube, Moss Nasal Tube û Mark IV 06/14/2019
K200082 MPS Medical, Inc. BD Univia RightFit Enteral Extension Sets and Transitional Adapters 07/30/2020
K140947 NESTLE HEALTHCARE NUTRITION, INC. COMPAT ENTERAL DELIVERY PUMP SETS 09/04/2014
K222678 Rockfield Medical Mobility+ Enteral Feeding System 10/27/2022
K201741 Syncro Medical Innovations, Inc. Gabriel 3 Way EnFit Valve 11/05/2020
K191784 Syncro Medical Innovations, Inc. Gabriel Feeding Tube with Balloon, and EnFit Connector 11/15/2019
K202357 Three Circles Consulting Limited Nutricare Clear-ISOSAF Nasogastric Feeding Tube 10/01/2020
K163586 TrovRx, Inc. dba Trovita Health Science Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector 03/17/2017
K170555 U Deliver Medical, LLC U Deliver Bolink ENFit Enteral Feeding Sets 08/17/2017
K190310 U Deliver Medical, LLC U Deliver Bolink ENFit Enteral Feeding Sets 05/31/2019
K192991 Vesco Medical LLC Vesco Medical Extension Feeding Set 08/03/2020
K170162 Vesco Medical, LLC Vesco Medical Nasoenteric Feeding Tubes 09/26/2017
K210971 Vonco Products EnteraLoc Flow 08/18/2021
K223683 Vonco Products EnteraLoc Flow 07/10/2023
K213356 Wilson-Cook Medical, Inc. Entuit PEG, Entuit PEGJ 01/20/2022
K142075 XERIDIEM (FORMERLY MRI) BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE 01/08/2015
K142297 XERIDIEM (FORMERLY MRI) Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set 01/08/2015
K171347 Xeridiem Medical Devices Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection 06/06/2017
K180708 Xeridiem Medical Devices, A Spectrum Plastics Group Company Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profi 10/18/2018
K232046 Xeridiem Medical Devices, A Spectrum Plastics Group Company Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection 10/06/2023
K142539 ZEVEX, INC. EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set 01/08/2015


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