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FDA 510(k)

AMSure® Enteral Feeding Syringe with ENFit Tip

K-Number: K171857 · 2018-03-30

ApplicantAmsino International, Inc.
Decision Date2018-03-30
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMSure® Enteral Feeding Syringe with ENFit Tip is a medical device manufactured by Amsino International, Inc.. It received FDA 510(k) clearance on 2018-03-30 under approval number K171857. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMSure® Enteral Feeding Syringe with ENFit Tip?

AMSure® Enteral Feeding Syringe with ENFit Tip is a medical device that received FDA 510(k) clearance on 2018-03-30. It is manufactured by Amsino International, Inc.. The 510(k) number is K171857.

When was AMSure® Enteral Feeding Syringe with ENFit Tip approved by the FDA?

AMSure® Enteral Feeding Syringe with ENFit Tip received FDA 510(k) clearance on 2018-03-30, under approval number K171857.

What company makes AMSure® Enteral Feeding Syringe with ENFit Tip?

AMSure® Enteral Feeding Syringe with ENFit Tip is manufactured by Amsino International, Inc..

What is the FDA product code for AMSure® Enteral Feeding Syringe with ENFit Tip?

The FDA product code for AMSure® Enteral Feeding Syringe with ENFit Tip is PNR.

Related Clinical Trials

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Other Devices by Amsino International, Inc.

K181445AMSure Hydrophilic Intermittent Catheter K181423AMSure Sterile Water, and Sterile Normal Saline for Wound Flush K173665AMSafe Sure-Lok Needle-Free Connector K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water K183473AMSafe(R) Pre-Filled Normal Saline Flush Syringe K200051PUGGLE Enteral Feeding Pump and Feeding Set

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Related Devices (Code: PNR)

K160855U&U Enteral SyringeU&U Medical Technology Co, Ltd. K162188Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)Vr Medical Technology K161963Monoject Enteral Syringe with ENFit ConnectorCovidien K161045MonojectCovidien K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)Neomed, Inc. K160419Monoject Enteral Feeding Syringe with ENFit ConnectorCovidien

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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