What is the FDA product code for SINGLE LUMEN NEEDLE?

The FDA product code for SINGLE LUMEN NEEDLE is MQE.

FDA 510(k)

<GEN>SINGLE LUMEN NEEDLE

K-Number: K991262 · 1999-09-09

Applicant<Genx> Intl., Inc.

Decision Date1999-09-09

Product CodeMQE

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

<GEN>SINGLE LUMEN NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is <Genx> Intl., Inc.. It received FDA 510(k) clearance on 1999-09-09 under 510(k) number K991262. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the <GEN>SINGLE LUMEN NEEDLE?

<GEN>SINGLE LUMEN NEEDLE is a medical device that received FDA 510(k) clearance on 1999-09-09. The listed applicant is <Genx> Intl., Inc.. The 510(k) number is K991262.

When did <GEN>SINGLE LUMEN NEEDLE receive FDA 510(k) clearance?

<GEN>SINGLE LUMEN NEEDLE received FDA 510(k) clearance on 1999-09-09, under 510(k) number K991262.

Who is the listed applicant for <GEN>SINGLE LUMEN NEEDLE?

The FDA 510(k) record lists <Genx> Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for <GEN>SINGLE LUMEN NEEDLE?

The FDA product code for <GEN>SINGLE LUMEN NEEDLE is MQE.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.