Home / 510(k) Clearances / K223683

510(k) K223683

EnteraLoc Flow by Vonco Products — Product Code PIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2023
Date Received
December 8, 2022
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 Vonco Products

  • K210971 — EnteraLoc Flow (August 18, 2021)

Other clearances for product code PIF

  • 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)
  • 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)