Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)

510(k) Number

K233477 ↗

FDA Product Code

MQL

Models / Variants

Cryo-straw (Type I, Type III)

Warming Kit (A-4ML, B-8ML)

Vitrification Kit (A-3ML, B-6ML)

Device Class

Class II

Regulation

21 CFR Part 884.6180

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• lVF Embryo Transfer Catheter

  Class I

  CE/MDR

• Oocyte Pick-up Needle

  Class IIa

  CE/MDR

• IVF Embryo Transfer Catheter

  Class I

  CE/MDR

• lVF Embryo Transfer Catheter

  Class I

  CE/MDR

• lVF Embryo Transfer Catheter

  Class I

  CE/MDR

• lVF Embryo Transfer Catheter

  Class I

  CE/MDR

See all devices from Shandong Wego Ruisheng Medical Device Co., Ltd. →

• What biological samples can the Cryo-straw vitrification system store?

  The Cryo-straw (Type I, Type III) is designed specifically for vitrifying and storing oocytes at the MII stage, pronuclear (PN) zygotes, cleavage-stage embryos, and blastocyst-stage embryos. Vitrification is a rapid-freezing technique that minimizes ice crystal formation, preserving cellular integrity for later use in assisted reproductive technologies.

• Are the Cryo-straw and associated kits single-use or reusable?

  The Cryo-straw and its companion kits (Vitrification Kit and Warming Kit) are explicitly labeled as single-use devices. This design ensures sterility and prevents cross-contamination between samples, which is critical in clinical fertility settings where sample integrity must be maintained.

• What volumes are available in the Vitrification and Warming Kits?

  The Vitrification Kit is available in two volumes: A-3mL and B-6mL, while the Warming Kit comes in A-4mL and B-8mL configurations. These volumes correspond to the reagents and solutions required for the vitrification (freezing) and thawing processes, respectively, ensuring compatibility with the Cryo-straw’s capacity.

• How should the Cryo-straw and kits be stored before use?

  The Cryo-straw and associated kits must be stored according to cryopreservation protocols to preserve sterility and functionality. They should be kept in a clean, dry environment at room temperature, away from direct sunlight or extreme temperatures, until ready for use. Once opened or exposed to cryogenic conditions, they must be handled per the manufacturer’s instructions to maintain sample integrity.

• What regulatory pathway does this device follow, and what does that mean for clinicians?

  This device follows the FDA’s 510(k) clearance pathway, classified as substantially equivalent to predicate devices under regulation 884.6180. Clinicians can rely on this clearance as evidence that the Cryo-straw and kits meet FDA standards for safety and effectiveness in vitrification procedures, ensuring compliance with reproductive medicine best practices.