BEUDAMED
    Product Code: MQE FDA class 2 21 CFR 884.6100

    Needle, Assisted Reproduction

    Obstetrics/Gynecology

    The Assisted Reproduction Needle is an obstetrics/gynecology device used in assisted reproductive technology (ART) procedures such as oocyte retrieval or intracytoplasmic sperm injection (ICSI), designed for precise puncture and aspiration or injection in reproductive medicine settings. Classified as FDA Class 2 under 21 CFR 884.6100, it requires 510(k) premarket notification. The product code is MQE, and it is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    32
    FEI Numbers
    28
    Registration Numbers
    28
    Unique Applicants
    27
    Years Active
    26

    Basic Information

    Product Code
    MQE
    Device Class
    FDA class 2
    Regulation Number
    884.6100
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 32 510(k) clearances via K numbers.

    K Number Device Name
    K240523 VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
    K232163 Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
    K190590 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)
    K191291 Wallace Dual Lumen Oocyte Recovery System
    K182959 Wallace Dual Lumen Oocyte Recovery System
    K171625 Single Lumen Ovum Aspiration Needles
    K171611 Double Lumen Ovum Aspiration Needles
    K172050 Follicle Aspiration Set, Reduced Single Lumen
    K162881 Kitazato OPU Needles
    K161970 Follicle Aspiration Set
    K141365 OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN
    K112462 KITAZATO OPU NEEDLE
    K082727 FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
    K051742 OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
    K032208 MONA LISA ASPIRATION NEEDLE
    K032015 EMBRYON ULTRASOUND NEEDLE GUIDE
    K031622 WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS
    K023930 COOPERSURGICAL OOCYTE RECOVERY NEEDLES
    K013497 FAS SET #4551
    K012068 WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
    K003056 OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218
    K000205 EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
    K000628 WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733
    K991271 OOCYTE ASPIRATION NEEDLE
    K994417 OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
    K992308 OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138
    K991264 <GENX> SINGLE LUMEN SIDEPORT NEEDLE
    K991262 <GEN>SINGLE LUMEN NEEDLE
    K991020 <GENX> DOUBLE LUMEN NEEDLE
    K991273 SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE
    K990913 HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU
    K983593 OVUM PICK-UP ASPIRATION NEEDLES

    FEI Numbers

    This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.