BEUDAMED
    Product Code: FHQ FDA class 1 21 CFR 876.4730

    Holder, Needle, Gastroenterologic

    Gastroenterology, Urology

    The Gastroenterologic Needle Holder is a surgical instrument used to grip and manipulate needles during suturing of gastrointestinal or urological tissues. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket notification required. The product code is FHQ, regulated under 21 CFR 876.4730, within the Gastroenterology, Urology medical specialty.

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    510(k)s
    7
    FEI Numbers
    339
    Registration Numbers
    339
    Unique Applicants
    6
    Years Active
    20

    Basic Information

    Product Code
    FHQ
    Device Class
    FDA class 1
    Regulation Number
    876.4730
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    4

    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 7 510(k) clearances via K numbers.

    K Number Device Name
    K974327 WINGED NEEDLE HOLDER
    K924196 LAPAROSCOPIC NEEDLE HOLDER
    K930330 ENDOSCOPIC NEEDLEHOLDER, MODIFICATION
    K920706 MAGNETIC POINT GUARD FOR SURGICAL NEEDLES
    K851780 25-230 TO 25-390 VARIOUS NEEDLE HOLDERS
    K851779 25-100,25-220 VARIOUS NEEDLE HOLDERS
    K771859 NEEDLE HOLDER, MICROVASCULAR

    FEI Numbers

    This FDA classification entry is associated with 339 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 339 registration numbers. Click on an entry to view related FDA registrations.