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Minvitro Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K241454

by Guangzhou Hehong Biotech Co., Ltd.

Identifiers

510(k) Number
K241454 FDA 510(k)
FDA Product Code
MQK FDA 510(k)
Models / Variants
MVT-VSN series FDA 510(k)EUDAMED
including MVT-VSNR FDA 510(k)EUDAMED
MVT-VSNY FDA 510(k)EUDAMED
MVT-VSNB FDA 510(k)EUDAMED
MVT-VSNG FDA 510(k)EUDAMED
MVT-VSNP FDA 510(k)EUDAMED

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 Minvitro Vitrification Straw is a cryopreservation container designed for vitrification of human reproductive cells and embryos. It is classified as labware for assisted reproduction and is specifically engineered to preserve oocytes (MII stage), 4-8 cell embryos, and blastocyst-stage embryos through ultra-rapid freezing techniques.

These straws are intended for single-use in clinical settings and are regulated under FDA 510(k) clearance and EU MDR compliance. The series includes multiple variants (MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) for compatibility with vitrification protocols, with no MRI safety restrictions noted. Storage and handling follow standard cryopreservation protocols to maintain sterility and integrity.

Frequently asked questions

What types of reproductive cells and embryos can the Minvitro Vitrification Straw preserve, and how does it achieve this?

The Minvitro Vitrification Straw (MVT-VSN series) is specifically designed to preserve oocytes at the MII stage, as well as embryos at the 4-8 cell and blastocyst stages. It achieves this through ultra-rapid freezing techniques known as vitrification, which minimizes ice crystal formation during cryopreservation, thereby protecting cellular integrity.

Are the Minvitro Vitrification Straws single-use or reusable, and what does this mean for clinical workflows?

The Minvitro Vitrification Straws are explicitly intended for single-use only in clinical settings. This design ensures sterility and prevents cross-contamination between patients, which is critical for maintaining safety and compliance in assisted reproduction workflows. Clinicians should discard them after one use to avoid potential risks.

What variants (MVT-VSNR, MVT-VSNY, etc.) are available, and how do they differ in clinical application?

The MVT-VSN series includes multiple variants (MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) tailored for compatibility with different vitrification protocols. While the exact differences between these variants aren’t detailed in the data, their inclusion suggests variations in straw dimensions, tip design, or material properties to optimize performance for specific cryopreservation systems or lab setups.

How should the Minvitro Vitrification Straws be stored to maintain sterility and functionality?

Storage and handling of the Minvitro Vitrification Straws follow standard cryopreservation protocols to preserve sterility and structural integrity. They should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use. Once opened or prepared for vitrification, they must be used immediately to prevent contamination or degradation, as they are not designed for long-term shelf storage post-sterilization.

What regulatory pathways does the Minvitro Vitrification Straw follow, and how does this affect its use in clinical settings?

The Minvitro Vitrification Straw is cleared under FDA 510(k) and complies with EU MDR, indicating it has undergone rigorous review for safety and effectiveness in its intended use. Clinicians can rely on these regulatory pathways to confirm the device meets established standards for labware in assisted reproduction. The Obstetrics/Gynecology (OB) advisory committee review further supports its classification as specialized equipment for reproductive cryopreservation.

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: PDF MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) Regulation Number: 21 ..., Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT ..., Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Guangzhou Hehong Biotech Co., Ltd.

Sources (2)

  • FDA 510(k) K241454 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026