G-Freezekit Blast
FDA 510(k)Class II (US FDA 510(k))
by Vitrolife AB
Identifiers
- 510(k) Number
- K032154 FDA 510(k)
- FDA Product Code
- MQL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.6180 FDA 510(k)
- Regulation Number
- 884.6180 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The G-FREEZEKIT BLAST is a device used for reproductive media applications. It is designed for use in obstetrics and gynecology settings.
The device is supplied by Vitrolife AB and has received FDA 510(k) clearance as substantially equivalent. It is classified as a Class II medical device with product code MQL.
Frequently asked questions
What is the G-FREEZEKIT BLAST used for?
The G-FREEZEKIT BLAST is a medical device designed specifically for reproductive media applications in obstetrics and gynecology settings. It is used to assist in procedures related to reproductive medicine.
What is the regulatory status of the G-FREEZEKIT BLAST?
The G-FREEZEKIT BLAST has received FDA 510(k) clearance as substantially equivalent. It is classified as a Class II medical device with product code MQL and is intended for use in obstetrics and gynecology settings.
How is the G-FREEZEKIT BLAST supplied?
The G-FREEZEKIT BLAST is supplied by Vitrolife AB. The device is manufactured to meet the specifications required for its intended use in reproductive media applications.
Is the G-FREEZEKIT BLAST a single-use device?
The device data does not specify whether the G-FREEZEKIT BLAST is designed for single-use or multiple uses. For specific information regarding reuse or disposal, please consult the manufacturer's instructions or contact Vitrolife AB directly.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032154 | Class II | Active |
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Manufacturer
- Manufacturer
- Vitrolife AB
Sources (1)
- FDA 510(k) K032154 24 fields · synced Sep 21, 2026