Gx-IVF, Gx-TL, Gx-MOPS PLUS

FDA 510(k)

Class II (US FDA 510(k))

510(k) K202862

Identifiers

510(k) Number: K202862 FDA 510(k)
FDA Product Code: MQL FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 884.6180 FDA 510(k)
Regulation Number: 884.6180 FDA 510(k)
Advisory Committee: Obstetrics/Gynecology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Gx-IVF, Gx-TL, Gx-MOPS PLUS is a media device used in reproductive applications, specifically in Obstetrics/Gynecology. It is designed to support oocyte and sperm function during fertilisation and embryo culture. The device has a unique combination of triple antioxidant protection for improved embryo viability.

The device is supplied as a Class 2 device with product code MQL and is cleared through the Traditional 510(k) pathway. It has been assigned the regulation number 884.6180 and has received FDA 510(k) clearance, indicated by the k number K202862. The device is intended for use in a clinical setting, with specific storage and handling requirements.

Frequently asked questions

What is the Gx-IVF device used for?

The Gx-IVF device is used to support oocyte and sperm function during fertilisation and embryo culture in reproductive applications.

How is the Gx-IVF device supplied?

The Gx-IVF device is supplied as a Class 2 device with product code MQL.

What are the storage and handling requirements for the Gx-IVF device?

The device has specific storage and handling requirements, intended for use in a clinical setting.

Is the Gx-IVF device cleared for use?

The Gx-IVF device has received FDA 510(k) clearance, indicated by the k number K202862, through the Traditional 510(k) pathway.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Gx Media - Vitrolife, G-IVF™ PLUS - Vitrolife, K202862 FDA 510 (k) - Gx-IVF | Vitrolife Sweden AB, Gx-IVF, Gx-TL, Gx-MOPS PLUS (K202862) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K202862	Class II	Active

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Manufacturer

Manufacturer: Vitrolife Sweden AB

Sources (1)

FDA 510(k) K202862 24 fields · synced Sep 26, 2026