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 |