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510(k) K203613

ENFit Reusable Enteral Syringe by Shantou Wealy Medical Instrument Co.,Ltd — Product Code PNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2021
Date Received
December 10, 2020
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 Shantou Wealy Medical Instrument Co.,Ltd

  • K222452 — Disposable Automatically Retractable Safety Syringes (with detachable needle) (November 23, 2022)
  • K210216 — Disposable Automatically Retractable Insulin Safety Syringe (March 4, 2022)
  • K203410 — ENFit Disposable Enteral Syringe (June 28, 2021)
  • K141640 — AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE (November 19, 2014)
  • K113587 — AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) (February 24, 2012)

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)
  • K231300 — Nutricair Enteral Syringe with ENFit (October 6, 2023)
  • 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)
  • 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)