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510(k) K233034

Mobility+ Enteral Feeding System OTC by Rockfield Medical — Product Code PIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2024
Date Received
September 25, 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 Rockfield Medical

  • K222678 — Mobility+ Enteral Feeding System (October 27, 2022)

Other clearances for product code PIF

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  • K250481 — Extension Feeding Set with ENFit™ Connectors (April 18, 2025)
  • K240052 — Disposable Enteral Feeding Sets (July 3, 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)
  • K213258 — Nasogastric Feeding Tubes - ENFit Port - PVC (June 9, 2022)
  • K213174 — Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection (May 19, 2022)