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510(k) K210598

Pediatric Nasogastric Feeding Tubes - Single ENFit Port by Cair Lgl — Product Code PIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2021
Date Received
March 1, 2021
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 Cair Lgl

  • K231299 — Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector (January 22, 2024)
  • K231300 — Nutricair Enteral Syringe with ENFit (October 6, 2023)
  • K213258 — Nasogastric Feeding Tubes - ENFit Port - PVC (June 9, 2022)
  • K171117 — Carefusion NeutraClear Needle-free connector (EL-NC1000) (September 1, 2017)
  • K171118 — Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) (August 15, 2017)
  • K171132 — Carefusion NeutraClear Needle-free connector (July 31, 2017)
  • K133073 — CAIR DRIVE, NEUTRACLEAR (March 20, 2014)

Other clearances for product code PIF

  • K254170 — Percutaneous Endoscopic Gastrostomy (PEG) Kit (March 20, 2026)
  • 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)