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FDA 510(k)

Disposable Enteral Feeding Syringe with Enfit Connector

K-Number: K193657 · 2020-09-12

ApplicantShinva Ande Healthcare Apparatus Co., Ltd.
Decision Date2020-09-12
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Enteral Feeding Syringe with Enfit Connector is a medical device manufactured by Shinva Ande Healthcare Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2020-09-12 under approval number K193657. 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 Disposable Enteral Feeding Syringe with Enfit Connector?

Disposable Enteral Feeding Syringe with Enfit Connector is a medical device that received FDA 510(k) clearance on 2020-09-12. It is manufactured by Shinva Ande Healthcare Apparatus Co., Ltd.. The 510(k) number is K193657.

When was Disposable Enteral Feeding Syringe with Enfit Connector approved by the FDA?

Disposable Enteral Feeding Syringe with Enfit Connector received FDA 510(k) clearance on 2020-09-12, under approval number K193657.

What company makes Disposable Enteral Feeding Syringe with Enfit Connector?

Disposable Enteral Feeding Syringe with Enfit Connector is manufactured by Shinva Ande Healthcare Apparatus Co., Ltd..

What is the FDA product code for Disposable Enteral Feeding Syringe with Enfit Connector?

The FDA product code for Disposable Enteral Feeding Syringe with Enfit Connector is PNR.

Related Clinical Trials

NCT06328894 Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients COMPLETED NCT06328985 Intermittent Oro-esophageal Tube Feeding in Traumatic Brain Injury Patients COMPLETED NCT01536782 Optimal Tube Feeding Method in Head and Neck Cancer Patients WITHDRAWN

Other Devices by Shinva Ande Healthcare Apparatus Co., Ltd.

K162601Infusion Set for Single Use K202060Disposable IV catheter K201460Closed System Transfer Device K220057Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization K211484Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles

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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