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510(k) K232046

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection by Xeridiem Medical Devices, A Spectrum Plastics Group Company — Product Code PIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2023
Date Received
July 10, 2023
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 Xeridiem Medical Devices, A Spectrum Plastics Group Company

  • K180708 — Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP G (October 18, 2018)

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  • K230326 — ENFit to ENFit Extension Sets (November 2, 2023)
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  • K213258 — Nasogastric Feeding Tubes - ENFit Port - PVC (June 9, 2022)
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