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G-2 V5

FDA 510(k)

Class II (US FDA 510(k))

510(k) K081117

by Vitrolife Sweden AB

Identifiers

510(k) Number
K081117 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 G-2 V5 is a reproductive media device designed for use in assisted reproductive technology (ART) procedures. Classified under the FDA’s product code MQL (Media, Reproductive), it serves as a culture medium for gametes and embryos, facilitating their growth and development in controlled laboratory conditions. Its role aligns with obstetrics and gynecology applications, supporting in vitro fertilization (IVF) and related fertility treatments by providing a sterile, nutrient-rich environment for reproductive cells.

Supplied as a sterile, single-use device, the G-2 V5 is intended for use in clinical settings such as IVF laboratories. It adheres to FDA’s Special Controls under regulation 884.6180 and holds a 510(k) clearance (K081117) for substantial equivalence, issued in 2008. The device is non-magnetic and compatible with standard laboratory practices, with no additional storage or handling requirements specified beyond standard sterile media protocols. Its classification as Class II reflects regulatory oversight for devices posing moderate risk.

Frequently asked questions

What is the G-2 V5 used for in assisted reproductive technology?

The G-2 V5 is a sterile, single-use culture medium designed specifically for assisted reproductive technology (ART) procedures. It provides a nutrient-rich, controlled environment for the growth and development of gametes (sperm and egg cells) and embryos during in vitro fertilization (IVF) and related fertility treatments. Its formulation aligns with FDA’s product code MQL (Media, Reproductive) and supports obstetrics/gynecology applications by maintaining optimal conditions for reproductive cells outside the body.

How is the G-2 V5 supplied, and what are its sterility and reuse considerations?

The G-2 V5 is supplied as a sterile, single-use device, meaning each unit is intended for one-time clinical use only. This design minimizes contamination risks and ensures consistency in reproductive cell culture. Since it is non-magnetic and adheres to standard sterile media protocols, no additional storage or handling precautions are required beyond those typically used for sterile laboratory media. Reuse is not recommended or supported by the manufacturer.

Does the G-2 V5 require special storage conditions, and what are its compatibility details?

The G-2 V5 does not have unique storage requirements beyond those standard for sterile culture media. It should be stored according to general laboratory practices for maintaining sterility, such as in a clean, dry environment away from direct light or extreme temperatures. The device is compatible with standard IVF laboratory practices and is non-magnetic, ensuring it won’t interfere with common lab equipment or procedures.

What regulatory clearance does the G-2 V5 hold, and how does it relate to its classification?

The G-2 V5 holds FDA 510(k) clearance (K081117), issued in 2008, under the classification of Class II devices. This clearance demonstrates substantial equivalence to a predicate device and reflects FDA’s regulatory oversight for devices posing moderate risk. The device is classified under product code MQL (Media, Reproductive) and adheres to FDA’s Special Controls under regulation 884.6180, ensuring it meets stringent standards for reproductive media used in clinical settings.

Are there different models or sizes available for the G-2 V5, and how are they distinguished?

The G-2 V5 is a specific model within Vitrolife’s reproductive media lineup, and while the provided data does not list variations in sizes or models beyond the V5 designation, it is typically supplied in standardized volumes optimized for IVF laboratory workflows. For precise details on packaging or volume specifications, refer to the manufacturer’s technical documentation or contact Vitrolife Sweden AB directly, as these may vary based on regional or procedural requirements.

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: K081117 FDA 510 (k) - G-2 V5 | Vitrolife Sweden AB, G-2 V5 510 (k) FDA Premarket Notification K081117 VITROLIFE SWEDEN AB, G-2 V5 - Beudamed, Vitrolife Sweden AB FDA 510 (k) Products - Latest 2025

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vitrolife Sweden AB

Sources (1)

  • FDA 510(k) K081117 24 fields · synced Oct 5, 2026