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510(k) K243652

Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) by Cardinalhealth — Product Code PNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2024
Date Received
November 26, 2024
Clearance Type
Special
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.

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Other clearances for product code PNR

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  • 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)