FDA Product Code PIF: Gastrointestinal Tubes With Enteral Specific Connectors
To Facilitate Enteral Specific Connections.
Leading manufacturers include Covidien, Medline Industries, Inc. and Vonco Products.
52
Total
52
Cleared
172d
Avg days
2014
Since
Stable submission activity - 5 submissions in the last 2 years
Consistent review times:
185d avg (recent)
FDA 510(k) Cleared Gastrointestinal Tubes With Enteral Specific Connectors Devices (Product Code PIF)
52 devices
Cleared
Sep 10, 2026
danumed Extension Set for Gastrostomy Button
Danumed Medizintechnik GmbH
Gastroenterology & Urology
239d
Cleared
Aug 26, 2026
Edi Catheter ENFit 6Fr/48 cm (6893166)
Maquet Critical Care AB
Gastroenterology & Urology
275d
Cleared
Mar 20, 2026
Percutaneous Endoscopic Gastrostomy (PEG) Kit
Degania Silicone , Ltd.
Gastroenterology & Urology
87d
Cleared
Jun 18, 2025
Enteral Drainage System, Enteral Medicine straw
Hmc Premedical S.P.A.
Gastroenterology & Urology
267d
Cleared
Apr 18, 2025
Extension Feeding Set with ENFit™ Connectors
SKY Medical, a.s.
Gastroenterology & Urology
58d
Cleared
Jul 03, 2024
Disposable Enteral Feeding Sets
Beijing L&Z Medical Technology Development Co., Ltd.
Gastroenterology & Urology
177d
Cleared
Apr 12, 2024
Mobility+ Enteral Feeding System OTC
Rockfield Medical
Gastroenterology & Urology
200d
Cleared
Nov 02, 2023
ENFit to ENFit Extension Sets
Vesco Medical
Gastroenterology & Urology
269d
Cleared
Oct 06, 2023
Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
Xeridiem Medical Devices, A Spectrum Plastics Group Company
Gastroenterology & Urology
88d
Cleared
Aug 17, 2023
Feeding Tube
Anhui Tiankang Medical Technology Co., Ltd.
Gastroenterology & Urology
337d
Cleared
Jul 10, 2023
EnteraLoc Flow
Vonco Products
Gastroenterology & Urology
214d
Cleared
Oct 27, 2022
Mobility+ Enteral Feeding System
Rockfield Medical
Gastroenterology & Urology
51d
Cleared
Jun 09, 2022
Nasogastric Feeding Tubes - ENFit Port - PVC
Cair Lgl
Gastroenterology & Urology
252d
Cleared
May 19, 2022
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
Cardinalhealth
Gastroenterology & Urology
233d
Cleared
Jan 20, 2022
Entuit PEG, Entuit PEGJ
Wilson-Cook Medical, Inc.
Gastroenterology & Urology
100d
Cleared
Nov 16, 2021
Enteral Feeding Set
Kb Medical (Group), Inc.
Gastroenterology & Urology
238d
Cleared
Nov 02, 2021
Pediatric Nasogastric Feeding Tubes - Single ENFit Port
Cair Lgl
Gastroenterology & Urology
246d
Cleared
Aug 19, 2021
Enteral Extension Sets
GBUK Group, Ltd.
Gastroenterology & Urology
251d
Cleared
Aug 18, 2021
EnteraLoc Flow
Vonco Products
Gastroenterology & Urology
140d
Cleared
Nov 05, 2020
Gabriel 3 Way EnFit Valve
Syncro Medical Innovations, Inc.
Gastroenterology & Urology
133d
Cleared
Oct 01, 2020
Nutricare Clear-ISOSAF Nasogastric Feeding Tube
Three Circles Consulting Limited
Gastroenterology & Urology
43d
Cleared
Aug 03, 2020
Vesco Medical Extension Feeding Set
Vesco Medical, LLC
Gastroenterology & Urology
283d
Cleared
Jul 30, 2020
BD Univia RightFit Enteral Extension Sets and Transitional Adapters
Mps Medical, Inc.
Gastroenterology & Urology
197d
Cleared
Dec 04, 2019
Medline Quick Switch Valve with ENFit Connector
Medline Industries, Inc.
Gastroenterology & Urology
156d
About Product Code PIF - Regulatory Context
510(k) Submission Activity
52 total 510(k) submissions under product code PIF since 2014, with 52 receiving FDA clearance (average review time: 172 days).
Submission volume has remained relatively stable over the observed period, with 5 submissions in the last 24 months.
FDA 510(k) Review Time - PIF Product Code
FDA review times for PIF submissions have been consistent, averaging 185 days recently vs 170 days historically.
PIF devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →