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FDA 510(k)

Oral/Enteral Syringe with ENFit connector

K-Number: K211025 · 2021-06-30

Decision Date2021-06-30
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Oral/Enteral Syringe with ENFit connector is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Tianyi Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2021-06-30 under 510(k) 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. The listed applicant is Ningbo Tianyi Medical Appliance Co., Ltd.. The 510(k) number is K211025.

When did Oral/Enteral Syringe with ENFit connector receive FDA 510(k) clearance?

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

Who is the listed applicant for Oral/Enteral Syringe with ENFit connector?

The FDA 510(k) record lists Ningbo Tianyi Medical Appliance Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Ningbo Tianyi Medical Appliance Co., Ltd. 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.

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.

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.