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510(k) K191784

Gabriel Feeding Tube with Balloon, and EnFit Connector by Syncro Medical Innovations, Inc. — Product Code PIF

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
November 15, 2019
Date Received
July 3, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gastrointestinal Tubes With Enteral Specific Connectors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

To facilitate enteral specific connections.

Other clearances by Syncro Medical Innovations, Inc.

  • K201741 — Gabriel 3 Way EnFit Valve (November 5, 2020)
  • K160787 — Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, G (August 9, 2016)
  • K110005 — SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE (August 4, 2011)
  • K072787 — GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111 (October 31, 2007)
  • K021991 — MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE (July 18, 2002)

Other clearances for product code PIF

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  • K242917 — Enteral Drainage System, Enteral Medicine straw (June 18, 2025)
  • K250481 — Extension Feeding Set with ENFit™ Connectors (April 18, 2025)
  • K240052 — Disposable Enteral Feeding Sets (July 3, 2024)
  • K233034 — Mobility+ Enteral Feeding System OTC (April 12, 2024)
  • K230326 — ENFit to ENFit Extension Sets (November 2, 2023)
  • K232046 — Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT (October 6, 2023)
  • K222773 — Feeding Tube (August 17, 2023)
  • K223683 — EnteraLoc Flow (July 10, 2023)
  • K222678 — Mobility+ Enteral Feeding System (October 27, 2022)