cryo-GO Vitrification Device

Q: What is the product code of K241341?

The FDA product code is MQK – Labware, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6160.

FDA 510(k) K241341 · Fujifilm Irvine Scientific

Substantially Equivalent

510(k) numberK241341

Submission

Device name: cryo-GO Vitrification Device
Applicant: Fujifilm Irvine Scientific
Santa Ana, CA, US
Received: May 13, 2024
Decision date: September 26, 2024
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MQK – Labware, Assisted Reproduction
Device class: Class II (moderate risk)
Regulation: 21 CFR 884.6160
Specialty: Obstetrics/Gynecology

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K221810	LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation DeviceMQK · Traditional	Bonraybio Co., Ltd.	10/31/2022SE
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K203626	SureStrip Vitrification Straw, SureLock Vitrification StrawMQK · Traditional	Allwin Medical Devices, Inc.	06/04/2021SE
K201213	Pasteur Pipette 3mL, Pasteur Pipette 1mLMQK · Traditional	Hertart Aps	12/16/2020SE

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Questions and answers

When was cryo-GO Vitrification Device cleared by the FDA?

cryo-GO Vitrification Device (K241341) received a 510(k) decision of Substantially Equivalent on September 26, 2024, 136 days after the submission was received.

What is the product code of K241341?

The FDA product code is MQK – Labware, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6160.