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FDA 510(k)

Closed Male Luer

K-Number: K171101 · 2017-06-02

ApplicantYukon Medical
Decision Date2017-06-02
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Closed Male Luer is the device name listed in this FDA 510(k) record. The listed applicant is Yukon Medical. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K171101. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Closed Male Luer?

Closed Male Luer is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Yukon Medical. The 510(k) number is K171101.

When did Closed Male Luer receive FDA 510(k) clearance?

Closed Male Luer received FDA 510(k) clearance on 2017-06-02, under 510(k) number K171101.

Who is the listed applicant for Closed Male Luer?

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

What is the FDA product code for Closed Male Luer?

The FDA product code for Closed Male Luer is FPA.

Other records listing Yukon Medical 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: FPA)

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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