FDA 510(k)

NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE

K-Number: K113469 · 2012-10-18

Decision Date2012-10-18

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corporation. It received FDA 510(k) clearance on 2012-10-18 under 510(k) number K113469. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE?

NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE is a medical device that received FDA 510(k) clearance on 2012-10-18. The listed applicant is Nipro Medical Corporation. The 510(k) number is K113469.

When did NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE receive FDA 510(k) clearance?

NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE received FDA 510(k) clearance on 2012-10-18, under 510(k) number K113469.

Who is the listed applicant for NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE?

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

What is the FDA product code for NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE?

The FDA product code for NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE is FMI.

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Related Devices (Code: FMI)

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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.