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FDA 510(k)

Oral/Enteral Syringe with ENFit connector

K-Number: K211025 · 2021-06-30

ApplicantNingbo Tianyi Medical Appliance Co., Ltd.
Decision Date2021-06-30
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Oral/Enteral Syringe with ENFit connector is a medical device manufactured by Ningbo Tianyi Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2021-06-30 under approval number K211025. 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 Oral/Enteral Syringe with ENFit connector?

Oral/Enteral Syringe with ENFit connector is a medical device that received FDA 510(k) clearance on 2021-06-30. It is manufactured by Ningbo Tianyi Medical Appliance Co., Ltd.. The 510(k) number is K211025.

When was Oral/Enteral Syringe with ENFit connector approved by the FDA?

Oral/Enteral Syringe with ENFit connector received FDA 510(k) clearance on 2021-06-30, under approval number K211025.

What company makes Oral/Enteral Syringe with ENFit connector?

Oral/Enteral Syringe with ENFit connector is manufactured by Ningbo Tianyi Medical Appliance Co., Ltd..

What is the FDA product code for Oral/Enteral Syringe with ENFit connector?

The FDA product code for Oral/Enteral Syringe with ENFit connector is PNR.

Other Devices by Ningbo Tianyi Medical Appliance Co., Ltd.

K210621Oral/Enteral Syringe K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)

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

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

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