Identifiers
- 510(k) Number
- K081114 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)
G-1 V5 is a reproductive medium classified under regulation number 884.6180. It is intended for use in reproductive procedures.
This device is supplied as a liquid and is subject to FDA 510(k) clearance. It is manufactured by Vitrolife Sweden AB, located in Kungsbacka, Sweden.
Frequently asked questions
What is the intended use of the G-1 V5 medium?
The G-1 V5 is a reproductive medium specifically intended for use in reproductive procedures. It is classified under regulation number 884.6180.
How is the G-1 V5 supplied?
The device is supplied as a liquid. It is manufactured by Vitrolife Sweden AB, which is based in Kungsbacka, Sweden.
What is the regulatory status of this device?
The G-1 V5 has received FDA 510(k) clearance. It was processed under a traditional submission route and is categorized as a class 2 medical device.
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: K081114 FDA 510 (k) - G-1 V5 | Vitrolife Sweden AB, G-1 V5 (K081114) — FDA 510 (k) | Innolitics, G-1 V5 PLUS Safety Data Sheet | SDS/MSDS - nextsds.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081114 | Class II | Active |
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Manufacturer
- Manufacturer
- Vitrolife Sweden AB
Sources (1)
- FDA 510(k) K081114 24 fields · synced Sep 22, 2026