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

    Follicle Aspiration Set, Reduced Single Lumen

    K Number: K172050 · Decision Nov 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    32
    Applicant Total
    38
    Review Days
    138

    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
    Follicle Aspiration Set, Reduced Single Lumen
    K Number
    K172050
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6100
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vitrolife Sweden AB
    Date Received
    July 6, 2017
    Decision Date
    November 21, 2017
    Product Code
    MQE
    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
    MQE Needle, Assisted Reproduction

    Similar 510(k) Clearances

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

    Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle

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

    VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)

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

    Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle

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

    Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)

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

    Wallace Dual Lumen Oocyte Recovery System

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

    Wallace Dual Lumen Oocyte Recovery System

    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
    K202862 Gx-IVF, Gx-TL, Gx-MOPS PLUS
    K183486 RapidVit™ Oocyte, RapidWarm™ Oocyte
    K181461 Rapid-i™ Kit
    K161970 Follicle Aspiration Set
    K150950 FreezeKit Cleave , ThawKit Cleave
    K140207 RAPID-I KIT
    K113786 SPERMFREEZE SOLUTION
    Search all 38 clearances from Vitrolife Sweden AB →