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510(k) K201741

Gabriel 3 Way EnFit Valve by Syncro Medical Innovations, Inc. — Product Code PIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2020
Date Received
June 25, 2020
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.

  • K191784 — Gabriel Feeding Tube with Balloon, and EnFit Connector (November 15, 2019)
  • 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)

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  • 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)