BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    Gx-IVF, Gx-TL, Gx-MOPS PLUS

    K Number: K202862 · Decision May 14, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    258
    Applicant Total
    38
    Review Days
    228

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Gx-IVF, Gx-TL, Gx-MOPS PLUS
    K Number
    K202862
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6180
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vitrolife Sweden AB
    Date Received
    September 28, 2020
    Decision Date
    May 14, 2021
    Product Code
    MQL
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQL Media, Reproductive

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MQL), ordered by most recent decision date.

    Ultra-Fast Warm

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Fast Warm - NX

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Ultra-Fast Vitri; Ultra-Fast Warm

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Vitrolife Sweden AB

    K Number Device Name
    K243373 Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)
    K241662 Ultrasound Transducer Cover
    K240605 Ultra RapidWarm™ Blast
    K183486 RapidVit™ Oocyte, RapidWarm™ Oocyte
    K181461 Rapid-i™ Kit
    K172050 Follicle Aspiration Set, Reduced Single Lumen
    K161970 Follicle Aspiration Set
    K150950 FreezeKit Cleave , ThawKit Cleave
    K140207 RAPID-I KIT
    K113786 SPERMFREEZE SOLUTION
    Search all 38 clearances from Vitrolife Sweden AB →