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VitriGuard

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200815

by Origio A/S

Identifiers

510(k) Number
K200815 FDA 510(k)
FDA Product Code
MQK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.6160 FDA 510(k)
Regulation Number
884.6160 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The VitriGuard is a Labware, Assisted Reproduction device, specifically designed as a vitrification carrier for cryopreservation of biological specimens. It facilitates the efficient and flexible storage of samples in liquid nitrogen, ensuring minimal thermal shock during the vitrification process by optimizing heat transfer and insulation properties. This device is engineered to maximize compatibility with standard cryopreservation protocols while maintaining structural integrity under cryogenic conditions.

VitriGuard is supplied as a single-use, non-sterile device intended for use in clinical or research settings where assisted reproduction procedures are performed. It is classified as a Class II medical device under FDA regulations (product code MQK) and is authorized for use in obstetrics and gynecology applications. The device is not MRI-safe and must be stored in a controlled environment, such as a cryogenic freezer, to preserve its functionality. No additional regulatory approvals beyond the FDA 510(k) clearance (K200815) are explicitly stated in the provided data.

Frequently asked questions

What is the VitriGuard designed for?

The VitriGuard is specifically designed as a vitrification carrier for cryopreservation of biological specimens in assisted reproduction procedures. It is engineered to minimize thermal shock during the vitrification process by optimizing heat transfer and insulation, ensuring samples remain stable when stored in liquid nitrogen. This makes it ideal for clinical and research settings where preserving fertility or genetic material is critical.

Is the VitriGuard sterile and single-use?

The VitriGuard is supplied as a single-use device but is not sterile. It is intended for use in controlled clinical or research environments where assisted reproduction procedures are performed. The non-sterile classification means it should not be used in sterile surgical settings without additional sterilization steps, though its single-use nature prevents reuse.

How should the VitriGuard be stored?

The VitriGuard must be stored in a controlled environment, specifically a cryogenic freezer, to maintain its functionality. It is not designed for room-temperature storage and should only be exposed to cryogenic temperatures when actively used for vitrification. Proper storage ensures the device retains its structural integrity and performance during cryopreservation.

Can the VitriGuard be used with standard cryopreservation protocols?

Yes, the VitriGuard is engineered to maximize compatibility with standard cryopreservation protocols. Its design focuses on optimizing heat transfer and insulation to protect biological specimens during the vitrification process, ensuring seamless integration with existing workflows in assisted reproduction settings.

Is the VitriGuard MRI-safe?

No, the VitriGuard is explicitly stated as not MRI-safe. This means it should not be placed in or near an MRI machine, as it could interfere with imaging or pose a risk to patients or equipment. Always verify device compatibility with MRI systems before use in any setting.

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: K200815 FDA 510 (k) - VitriGuard | Origio A/S, Origio A/S FDA 510 (k) Products (2010-2020), ORIGIO VITRIGUARD INSTRUCTIONS FOR USE Pdf Download, VITRIGUARD - Origio A/S Trademark Registration, PDF VITRIFICATION BY ORIGIO ORIGIO Vitrification

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Origio A/S

Sources (1)

  • FDA 510(k) K200815 24 fields · synced Oct 1, 2026