What is the FDA product code for SINGLE LUMEN SIDEPORT NEEDLE?

The FDA product code for SINGLE LUMEN SIDEPORT NEEDLE is MQE.

FDA 510(k)

<GENX> SINGLE LUMEN SIDEPORT NEEDLE

K-Number: K991264 · 1999-09-09

Applicant<Genx> Intl., Inc.

Decision Date1999-09-09

Product CodeMQE

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

<GENX> SINGLE LUMEN SIDEPORT 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 K991264. 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 <GENX> SINGLE LUMEN SIDEPORT NEEDLE?

<GENX> SINGLE LUMEN SIDEPORT 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 K991264.

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

<GENX> SINGLE LUMEN SIDEPORT NEEDLE received FDA 510(k) clearance on 1999-09-09, under 510(k) number K991264.

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

The FDA product code for <GENX> SINGLE LUMEN SIDEPORT 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.