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510(k) K171857

AMSure® Enteral Feeding Syringe with ENFit Tip by Amsino International, Inc. — Product Code PNR

K171857 is an FDA 510(k) premarket notification submitted by Amsino International, Inc. for the device "AMSure® Enteral Feeding Syringe with ENFit Tip". The FDA issued a decision of Substantially Equivalent on March 30, 2018. The device falls under product code PNR (Enteral Syringes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Amsino International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2018
Date Received
June 21, 2017
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 Amsino International, Inc.

  • K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, (May 4, 2026)
  • K220230 — AMSure Enteral Feeding Pump (November 10, 2022)
  • K220267 — AMSafe NeuFlo Needleless Connector (October 7, 2022)
  • K213522 — AMSafe Pre-Filled Normal Saline Flush Syringe (March 22, 2022)
  • K200051 — PUGGLE Enteral Feeding Pump and Feeding Set (September 25, 2020)
  • K183473 — AMSafe(R) Pre-Filled Normal Saline Flush Syringe (July 12, 2019)
  • K181445 — AMSure Hydrophilic Intermittent Catheter (October 1, 2018)
  • K181423 — AMSure Sterile Water, and Sterile Normal Saline for Wound Flush (September 7, 2018)
  • K173665 — AMSafe Sure-Lok Needle-Free Connector (September 5, 2018)
  • K181814 — AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water (September 4, 2018)

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