PIF · Class II · 21 CFR 876.5980

FDA Product Code PIF: Gastrointestinal Tubes With Enteral Specific Connectors

To Facilitate Enteral Specific Connections.

Leading manufacturers include Medline Industries, Inc., Cair Lgl and Vonco Products.

50
Total
50
Cleared
169d
Avg days
2014
Since
50 devices
25–48 of 50
Cleared Jun 14, 2019
Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV
K190414
Moss Tubes, Inc.
Gastroenterology & Urology · 113d
Cleared May 31, 2019
U Deliver Bolink ENFit Enteral Feeding Sets
K190310
U Deliver Medical, LLC
Gastroenterology & Urology · 108d
Cleared Apr 25, 2019
Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
K181787
Cedic S.R.L.
Gastroenterology & Urology · 294d
Cleared Apr 09, 2019
ENConnect 40 mm Screw Cap to ENPlus Adapter
K190327
Cedic S.R.L.
Gastroenterology & Urology · 55d
Cleared Oct 18, 2018
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 Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit
K180708
Xeridiem Medical Devices, A Spectrum Plastics Group Company
Gastroenterology & Urology · 213d
Cleared Jul 12, 2018
CONOD Enteral Feeding Sets
K181276
Conod Medical Co., Limited
Gastroenterology & Urology · 59d
Cleared Nov 29, 2016
Medline ENFit Syringe
K160642
Medline Industries, Inc.
Gastroenterology & Urology · 267d
Cleared Jun 17, 2016
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 Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector
K161003
Boston Scientific Corporation
Gastroenterology & Urology · 67d
Cleared May 29, 2015
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
K150679
Boston Scientific Corp
Gastroenterology & Urology · 73d
Cleared Apr 27, 2015
Medline Enteral Feeding Sets
K150286
Medline Industries, Inc.
Gastroenterology & Urology · 81d