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Cryotop US-Flash and Cryotop US-Scoop

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K181469

by Kitazato Corporation

Identifiers

510(k) Number
K181469 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 Cryotop US-Flash and Cryotop US-Scoop are cryopreservation storage devices classified as labware for assisted reproduction. They are designed specifically for vitrification procedures to safely contain and preserve human oocytes and embryos during cryogenic storage, ensuring structural integrity and viability.

These devices are intended for single-use in clinical settings, such as fertility clinics, and are supplied sterile. They are non-magnetic and MRI-safe, available in standardized sizes for compatibility with vitrification protocols. Authorized under FDA 510(k) and MDR, they comply with regulatory standards for obstetrics/gynecology applications under product code MQK.

Frequently asked questions

What clinical settings are the Cryotop®US-flash and Cryotop®US-scoop designed for, and how are they used?

The Cryotop®US-flash and Cryotop®US-scoop are specifically designed for fertility clinics and other clinical settings where assisted reproduction procedures are performed. They are intended for single-use in vitrification protocols, which is a method of cryopreservation used to safely store human oocytes (eggs) and embryos. Their purpose is to maintain the structural integrity and viability of these biological samples during cryogenic storage, ensuring they remain suitable for future use in fertility treatments.

Are the Cryotop®US-flash and Cryotop®US-scoop reusable, and what does this mean for their sterility?

No, the Cryotop®US-flash and Cryotop®US-scoop are explicitly designed for single-use only. This means each device is sterile upon packaging and should not be reused after a single procedure. Single-use ensures patient safety by eliminating the risk of cross-contamination between samples, which is critical when handling delicate biological materials like oocytes and embryos.

What storage conditions should be followed for the Cryotop®US-flash and Cryotop®US-scoop before use?

While the exact storage conditions aren’t detailed in the provided data, the fact that they are sterile and intended for single-use implies they should be stored in a clean, dry environment, protected from contamination and extreme temperatures. Always follow the manufacturer’s instructions (Kitazato Corporation) for optimal shelf-life and sterility preservation, particularly if they are shipped or stored for extended periods.

Are there different sizes or models of Cryotop®US-flash and Cryotop®US-scoop, and how do they relate to vitrification protocols?

Yes, the Cryotop®US-flash and Cryotop®US-scoop come in standardized sizes to ensure compatibility with various vitrification protocols. The

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: Cryotop®US-flash and Cryotop®US-scoop (K181469) — FDA 510 (k) | Innolitics, PDF Cryotop®US-flash Cryotop®US-scoop - Kitazato IVF, K181469 FDA 510 (k) - CryotopUS-flash and CryotopUS-scoop, Cryotop® | Vitrification Media and Equipments | KITAZATO CORPORATION

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kitazato Corporation

Sources (2)

  • FDA 510(k) K181469 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026