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510(k) K231300

Nutricair Enteral Syringe with ENFit by Cair Lgl — Product Code PNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2023
Date Received
May 4, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enteral Syringes With Enteral Specific Connectors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.

Other clearances by Cair Lgl

  • K231299 — Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector (January 22, 2024)
  • K213258 — Nasogastric Feeding Tubes - ENFit Port - PVC (June 9, 2022)
  • K210598 — Pediatric Nasogastric Feeding Tubes - Single ENFit Port (November 2, 2021)
  • 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 PNR

  • K251585 — Profoject™ Enteral Feeding Syringe (July 18, 2025)
  • K243652 — Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syring (December 19, 2024)
  • K222772 — Oral/Enteral Syringe with ENFit connector (August 17, 2023)
  • K222155 — Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket sy (September 16, 2022)
  • K211661 — ENFit enteral syringes (NUTRIFIT) (February 28, 2022)
  • K211593 — Enteral Pump Syringe (September 30, 2021)
  • K203613 — ENFit Reusable Enteral Syringe (August 27, 2021)
  • K211025 — Oral/Enteral Syringe with ENFit connector (June 30, 2021)
  • K203410 — ENFit Disposable Enteral Syringe (June 28, 2021)
  • K210621 — Oral/Enteral Syringe (April 28, 2021)