BEUDAMED
    Product Code: KNH FDA class 3 21 CFR 884.5380

    Laparoscopic Contraceptive Tubal Occlusion Device

    Obstetrics/Gynecology

    A Laparoscopic Contraceptive Tubal Occlusion Device is a surgically implanted device used to achieve permanent female sterilization by occluding the fallopian tubes via laparoscopic placement, preventing the passage of eggs and fertilization. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) due to its significant risk and irreversible nature; the FDA issued a call for PMAs to be filed by December 30, 1987 (52 FR 36883, October 1, 1987). The product code is KNH and it is regulated under 21 CFR 884.5380 in the Obstetrics and Gynecology specialty. This device is an implant.

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    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    KNH
    Device Class
    FDA class 3
    Regulation Number
    884.5380
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    2

    Device Characteristics

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

    Definition

    Call for PMAs to be filed by 12/30/87 (52 FR 36883 (10/1/87))

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.