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FDA 510(k)

Unger Quad Injector

K-Number: K161483 · 2016-10-31

ApplicantStradis Healthcare
Decision Date2016-10-31
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

Unger Quad Injector is the device name listed in this FDA 510(k) record. The listed applicant is Stradis Healthcare. It received FDA 510(k) clearance on 2016-10-31 under 510(k) number K161483. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unger Quad Injector?

Unger Quad Injector is a medical device that received FDA 510(k) clearance on 2016-10-31. The listed applicant is Stradis Healthcare. The 510(k) number is K161483.

When did Unger Quad Injector receive FDA 510(k) clearance?

Unger Quad Injector received FDA 510(k) clearance on 2016-10-31, under 510(k) number K161483.

Who is the listed applicant for Unger Quad Injector?

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

What is the FDA product code for Unger Quad Injector?

The FDA product code for Unger Quad Injector is LCJ.

Related Devices (Code: LCJ)

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.

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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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