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GENX Sperm Washing Media

by <Genx> Intl., Inc. 510(k)

Active United States

510(k) K991022

Overview

The device is a reproductive media used for sperm washing, classified as Media, Reproductive under product code MQL and device class II. It is a substantially equivalent device cleared via the traditional 510(k) pathway (K991022) and falls under the Obstetrics/Gynecology medical specialty.

It is supplied by Genx Intl., Inc. located at 170 Fort Path Rd., Unit 14, Madison, CT 06443, United States. The device received FDA 510(k) clearance on September 9, 1999, following submission on March 29, 1999, and is not indicated for any specific clinical use beyond its classification as reproductive media.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK991022 Date9 Sep 1999ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MQL
Device Class
Class II
Regulation
21 CFR Part 884.6180
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Other devices from <Genx> Intl., Inc.

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Questions

  • What is the <GENX> SPERM WASHING MEDIA used for?

    The <GENX> SPERM WASHING MEDIA is a reproductive media used for sperm washing, classified under product code MQL as Media, Reproductive, and is intended for use in preparing sperm for assisted reproductive procedures as part of its general classification as reproductive media.

  • How is the <GENX> SPERM WASHING MEDIA supplied and by whom?

    The device is supplied by Genx Intl., Inc., located at 170 Fort Path Rd., Unit 14, Madison, CT 06443, United States, as indicated in the manufacturer and address details from the FDA 510(k) record.

  • What regulatory pathway was used to clear the <GENX> SPERM WASHING MEDIA?

    The <GENX> SPERM WASHING MEDIA was cleared via the traditional 510(k) pathway under K991022, with a decision date of September 9, 1999, following submission on March 29, 1999, and was determined to be substantially equivalent to a predicate device.