ClearanceBrief
Panels › Gastroenterology, Urology › Product code PIF · Class 2

Gastrointestinal Tubes With Enteral Specific Connectors

Regulation 876.5980

3510(k)s in 12 months (52 all time)
1recalls in 12 months (112 all time)
111recalls that name a 510(k)
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Top companies in PIF

Company510(k)sRecalls
Xeridiem Mediem Medical Devices Inc0105
Boston Scientific Corp24
Covidien30
Medline Industries, Inc.30
Vesco Medical30
Applied Medical Technology, Inc.11
Cair Lgl20
Cardinalhealth20
Cedic S.R.L.20
Degania Silicone , Ltd.20
Decided510(k)Device and applicantCode
Sep 10, 2026K260110danumed Extension Set for Gastrostomy Button
Danumed Medizintechnik GmbH, DE
PIF
Aug 26, 2026K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Ed
Maquet Critical Care AB, SE
PIF
Mar 20, 2026K254170Percutaneous Endoscopic Gastrostomy (PEG) Kit
Degania Silicone , Ltd., IL
PIF
Jun 18, 2025K242917Enteral Drainage System, Enteral Medicine straw
HMC Premedical S.p.A., IT
PIF
Apr 18, 2025K250481Extension Feeding Set with ENFit™ Connectors
SKY Medical, a.s., SK
PIF
Jul 3, 2024K240052Disposable Enteral Feeding Sets
Beijing L&Z Medical Technology Development Co., Ltd., CN
PIF
Apr 12, 2024K233034Mobility+ Enteral Feeding System OTC
Rockfield Medical, IE
PIF
Nov 2, 2023K230326ENFit to ENFit Extension Sets
Vesco Medical
PIF
Oct 6, 2023K232046Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set
Xeridiem Medical Devices, A Spectrum Plastics Group Company
PIF
Aug 17, 2023K222773Feeding Tube
Anhui Tiankang Medical Technology Co., Ltd., CN
PIF
Jul 10, 2023K223683EnteraLoc Flow
Vonco Products
PIF
Oct 27, 2022K222678Mobility+ Enteral Feeding System
Rockfield Medical, IE
PIF
Jun 9, 2022K213258Nasogastric Feeding Tubes - ENFit Port - PVC
Cair Lgl, FR
PIF
May 19, 2022K213174Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
Cardinalhealth
PIF
Jan 20, 2022K213356Entuit PEG, Entuit PEGJ
Wilson-Cook Medical, Inc.
PIF
Nov 16, 2021K210854Enteral Feeding Set
Kb Medical (Group), Inc.
PIF
Nov 2, 2021K210598Pediatric Nasogastric Feeding Tubes - Single ENFit Port
Cair Lgl, FR
PIF
Aug 19, 2021K203633Enteral Extension Sets
GBUK Group, Ltd., GB
PIF
Aug 18, 2021K210971EnteraLoc Flow
Vonco Products
PIF
Nov 5, 2020K201741Gabriel 3 Way EnFit Valve
Syncro Medical Innovations, Inc.
PIF
Oct 1, 2020K202357Nutricare Clear-ISOSAF Nasogastric Feeding Tube
Three Circles Consulting Limited, GB
PIF
Aug 3, 2020K192991Vesco Medical Extension Feeding Set
Vesco Medical, LLC
PIF
Jul 30, 2020K200082BD Univia RightFit Enteral Extension Sets and Transitional Adapters
Mps Medical, Inc.
PIF
Dec 4, 2019K191759Medline Quick Switch Valve with ENFit Connector
Medline Industries, Inc.
PIF
Nov 15, 2019K191784Gabriel Feeding Tube with Balloon, and EnFit Connector
Syncro Medical Innovations, Inc.
PIF
Nov 7, 2019K190923Salem Sump Dual Lumen Stomach Tube with ENFit Connection
Cardinalhealth
PIF
Jun 14, 2019K190414Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV
Moss Tubes, Inc.
PIF
May 31, 2019K190310U Deliver Bolink ENFit Enteral Feeding Sets
U Deliver Medical, LLC
PIF
Apr 25, 2019K181787Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
Cedic S.R.L., IT
PIF
Apr 9, 2019K190327ENConnect 40 mm Screw Cap to ENPlus Adapter
Cedic S.R.L., IT
PIF
Oct 18, 2018K180708Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retent
Xeridiem Medical Devices, A Spectrum Plastics Group Company
PIF
Jul 12, 2018K181276CONOD Enteral Feeding Sets
Conod Medical Co., Limited, CN
PIF
Sep 26, 2017K170162Vesco Medical Nasoenteric Feeding Tubes
Vesco Medical, LLC
PIF
Aug 17, 2017K170555U Deliver Bolink ENFit Enteral Feeding Sets
U Deliver Medical, LLC
PIF
Jun 6, 2017K171347Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feedin
Xeridiem Medical Devices
PIF
Mar 17, 2017K163586Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
Trovrx, Inc. Dba Trovita Health Science
PIF
Mar 2, 2017K153688Edi Catheter ENFit
Maquet Critical Care AB, SE
PIF
Nov 29, 2016K160642Medline ENFit Syringe
Medline Industries, Inc.
PIF
Jun 17, 2016K161003EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replace
Boston Scientific Corporation
PIF
Apr 5, 2016K151503NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE
Gbuk Enteral Limited, GB
PIF
Oct 8, 2015K150711Salem Sump Dual Lumen Stomach Tube with Multi-functional Port
Covidien
PIF
Jul 13, 2015K150084Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connect
Covidien
PIF
May 29, 2015K150679EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit C
Boston Scientific Corp
PIF
Apr 27, 2015K150286Medline Enteral Feeding Sets
Medline Industries, Inc.
PIF
Apr 2, 2015K143018Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors
Covidien
PIF
Jan 29, 2015K142989Mini ONE Enteral Extension Set
Applied Medical Technology, Inc.
PIF
Jan 8, 2015K142539EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set
Zevex, Inc.
PIF
Jan 8, 2015K142297Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vi
Xeridiem (Formerly Mri)
PIF
Jan 8, 2015K142075BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE
Xeridiem (Formerly Mri)
PIF
Nov 20, 2014K142012FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS
Corpak Medsystems
PIF

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