FDA 510(k)

U&U Enteral Syringe

K-Number: K160855 · 2016-11-22

ApplicantU&U Medical Technology Co, Ltd.

Decision Date2016-11-22

Product CodePNR

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

U&U Enteral Syringe is the device name listed in this FDA 510(k) record. The listed applicant is U&U Medical Technology Co, Ltd.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K160855. 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 U&U Enteral Syringe?

U&U Enteral Syringe is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is U&U Medical Technology Co, Ltd.. The 510(k) number is K160855.

When did U&U Enteral Syringe receive FDA 510(k) clearance?

U&U Enteral Syringe received FDA 510(k) clearance on 2016-11-22, under 510(k) number K160855.

Who is the listed applicant for U&U Enteral Syringe?

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

What is the FDA product code for U&U Enteral Syringe?

The FDA product code for U&U Enteral Syringe is PNR.

Other records listing U&U Medical Technology 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.

K181508U&U Blood Collection Sets K171823U&U Indicator tape and strip K152808U&U Insulin Syringe with/without Safety Retractable Device

Related Devices (Code: PNR)

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.