Skip to content

Scandinavian Ivf Sciences Ab, G2.2

by Vitrolife AB/Scandinavian Ivf Sciences AB 510(k)

Active United States

510(k) K000619

Overview

The Scandinavian Ivf Sciences Ab, G2.2 is a media device used in reproductive procedures. It is classified as a Class II medical device and is intended for use in obstetrics and gynecology applications.

The device is manufactured by Vitrolife AB/Scandinavian Ivf Sciences AB and was cleared by the FDA through a 510(k) process on June 27, 2000. It is supplied as a sterile, single-use device and is not indicated for MRI use. The device is stored according to the manufacturer's instructions and is authorized for use in the United States.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK000619 Date27 Jun 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MQL
Device Class
Class II
Regulation
21 CFR Part 884.6180
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Other devices from Vitrolife AB/Scandinavian Ivf Sciences AB

Questions

  • What is the SCANDINAVIAN IVF SCIENCES AB, G2.2 device used for?

    The SCANDINAVIAN IVF SCIENCES AB, G2.2 is a media device specifically designed for use in reproductive procedures within obstetrics and gynecology applications. It serves as a Class II medical device to support various assisted reproductive technologies.

  • How is the SCANDINAVIAN IVF SCIENCES AB, G2.2 supplied and what is its sterility status?

    The device is supplied as a sterile, single-use medical device. This means it comes pre-sterilized by the manufacturer and should be used only once for each patient to maintain sterility and prevent cross-contamination, then properly disposed of after use.

  • What regulatory status does the SCANDINAVIAN IVF SCIENCES AB, G2.2 have?

    The device was cleared by the FDA through a 510(k) process on June 27, 2000, with the decision code SESE indicating it was found to be substantially equivalent to predicate devices. It is authorized for use in the United States as a Class II medical device.

  • Are there any special storage requirements for the SCANDINAVIAN IVF SCIENCES AB, G2.2?

    The device should be stored according to the manufacturer's instructions to maintain its integrity and sterility. While specific storage conditions aren't detailed in the provided information, it's standard practice to store such medical devices in a controlled environment away from extreme temperatures and contaminants.