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FDA 510(k)

Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)

K-Number: K162188 · 2016-09-22

ApplicantVr Medical Technology
Decision Date2016-09-22
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) is the device name listed in this FDA 510(k) record. The listed applicant is Vr Medical Technology. It received FDA 510(k) clearance on 2016-09-22 under 510(k) number K162188. 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 Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)?

Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) is a medical device that received FDA 510(k) clearance on 2016-09-22. The listed applicant is Vr Medical Technology. The 510(k) number is K162188.

When did Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) receive FDA 510(k) clearance?

Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) received FDA 510(k) clearance on 2016-09-22, under 510(k) number K162188.

Who is the listed applicant for Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)?

The FDA 510(k) record lists Vr Medical Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)?

The FDA product code for Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) is PNR.

Other records listing Vr Medical Technology as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180236VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)

Related Devices (Code: PNR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252483Enteral Syringe (20ml, 60ml)Chirana T.Injecta,A.S.K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes CapCMT Health PTE., Ltd.K251585Profoject™ Enteral Feeding SyringeCMT Health PTE., Ltd.K243652Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE)CardinalhealthK231300Nutricair Enteral Syringe with ENFitCair LglK222772Oral/Enteral Syringe with ENFit connectorAnhui Tiankang Medical Technology Co., Ltd.

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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