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510(k) K193657

Disposable Enteral Feeding Syringe with Enfit Connector by Shinva Ande Healthcare Apparatus Co., Ltd. — Product Code PNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2020
Date Received
December 30, 2019
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 Shinva Ande Healthcare Apparatus Co., Ltd.

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  • K220057 — Disposable Sterile Syringe with permanently attached needle; Auto-disable Syring (October 7, 2022)
  • K211484 — Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with N (March 1, 2022)
  • K202060 — Disposable IV catheter (July 23, 2021)
  • K162601 — Infusion Set for Single Use (May 31, 2017)

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)
  • 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)