BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SPERMCHECK VASECTOMY

    K Number: K073039 · Decision Jan 24, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    27
    Applicant Total
    72
    Review Days
    87

    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
    SPERMCHECK VASECTOMY
    K Number
    K073039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Princeton BioMeditech Corp.
    Date Received
    October 29, 2007
    Decision Date
    January 24, 2008
    Product Code
    POV
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    POV Semen Analysis Device

    Similar 510(k) Clearances

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

    Seaman Pro/Seaman

    FDA 510(k)
    FDA Class 2 ·Hematology

    LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology

    LensHooke X12 PRO Semen Analysis System

    FDA 510(k)
    FDA Class 2 ·Hematology

    SQA-iOw Sperm Quality Analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology

    YO Home Sperm Test

    FDA 510(k)
    FDA Class 2 ·Hematology

    SQA-iO Sperm Quality Analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all

    Other Clearances by Princeton BioMeditech Corp.

    K Number Device Name
    K251538 Status™ COVID-19/Flu A&B
    K182157 BioSign Flu A+B
    K130650 STATUS DS OXY
    K133474 BIOSIGN FLU A + B, STATUS FLU A & B
    K132465 BIOSIGN FLU A + B, STATUS FLU A & B
    K083746 BIOSIGN FLU A+B
    K100817 BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
    K100341 SPERMCHECK FERTILITY
    K082661 BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
    K062575 MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP
    Search all 72 clearances from Princeton BioMeditech Corp. →