BEUDAMED
    Product Code: MIC FDA class 2 21 CFR 874.3620

    Implant, Muscle, Pectoralis

    Ear, Nose, Throat

    The Pectoralis Muscle Implant is a surgically placed silicone or other biocompatible material device used for cosmetic or reconstructive augmentation of the pectoral region, typically to improve the contour and appearance of the chest in patients who have undergone surgery or have congenital anomalies. Classified as a Class 2 implantable device under 21 CFR 874.3620 within the Ear, Nose, and Throat specialty, it requires 510(k) premarket notification. It carries an implant flag, denoting its surgically implanted nature.

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    510(k)s
    8
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    7
    Years Active
    10

    Basic Information

    Product Code
    MIC
    Device Class
    FDA class 2
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    SU
    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 8 510(k) clearances via K numbers.

    K Number Device Name
    K021337 AART PECTORALIS IMPLANT
    K002633 SILMAX PECTORAL IMPLANT
    K983043 SEARE BIOMEDICAL SILICONE BLOCK
    K982762 SEARE BIOMEDICAL PECTORALIS IMPLANT
    K973729 POWERFLEX PEC IMPLANT
    K961072 PEC IMPLANT
    K944163 SPECTRUM DISIGNS PECTORAL IMPLANT
    K913768 PEC IMPLANT

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.