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510(k) K203410

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

K203410 is an FDA 510(k) premarket notification submitted by Shantou Wealy Medical Instrument Co.,Ltd for the device "ENFit Disposable Enteral Syringe". The FDA issued a decision of Substantially Equivalent on June 28, 2021. The device falls under product code PNR (Enteral Syringes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Shantou Wealy Medical Instrument Co.,Ltd has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2021
Date Received
November 19, 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)
  • K203613 — ENFit Reusable Enteral Syringe (August 27, 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

  • K252483 — Enteral Syringe (20ml, 60ml) (July 1, 2026)
  • K253268 — Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding (April 8, 2026)
  • 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)
  • 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)

FDA data resources