PIF — Gastrointestinal Tubes With Enteral Specific Connectors Class II

FDA Device Classification

Classification Details

Product Code
PIF
Device Class
Class II
Regulation Number
876.5980
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

To facilitate enteral specific connections.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242917hmc premedicalEnteral Drainage System, Enteral Medicine strawJune 18, 2025
K250481sky medical, a.sExtension Feeding Set with ENFit™ ConnectorsApril 18, 2025
K240052beijing l and z medical technology development coDisposable Enteral Feeding SetsJuly 3, 2024
K233034rockfield medicalMobility+ Enteral Feeding System OTCApril 12, 2024
K230326vesco medicalENFit to ENFit Extension SetsNovember 2, 2023
K232046xeridiem medical devices, a spectrum plastics groupKangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT October 6, 2023
K222773anhui tiankang medical technology coFeeding TubeAugust 17, 2023
K223683vonco productsEnteraLoc FlowJuly 10, 2023
K222678rockfield medicalMobility+ Enteral Feeding SystemOctober 27, 2022
K213258cair lglNasogastric Feeding Tubes - ENFit Port - PVCJune 9, 2022
K213174cardinalhealthSalem Sump Silicone Dual Lumen Stomach Tube with ENFit ConnectionMay 19, 2022
K213356wilson-cook medicalEntuit PEG, Entuit PEGJJanuary 20, 2022
K210854kb medical (group)Enteral Feeding SetNovember 16, 2021
K210598cair lglPediatric Nasogastric Feeding Tubes - Single ENFit PortNovember 2, 2021
K203633gbuk groupEnteral Extension SetsAugust 19, 2021
K210971vonco productsEnteraLoc FlowAugust 18, 2021
K201741syncro medical innovationsGabriel 3 Way EnFit ValveNovember 5, 2020
K202357three circles consulting limitedNutricare Clear-ISOSAF Nasogastric Feeding TubeOctober 1, 2020
K192991vesco medicalVesco Medical Extension Feeding SetAugust 3, 2020
K200082mps medicalBD Univia RightFit Enteral Extension Sets and Transitional AdaptersJuly 30, 2020