BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet

    K Number: K221368 · Decision Jun 9, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    105
    Applicant Total
    31
    Review Days
    28

    Basic Information

    Device Name
    Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
    K Number
    K221368
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Promisemed Hangzhou Meditech Co., Ltd.
    Date Received
    May 12, 2022
    Decision Date
    June 9, 2022
    Product Code
    FMK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

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    Other Clearances by Promisemed Hangzhou Meditech Co., Ltd.

    K Number Device Name
    K250961 Blood collection tube holders
    K251138 Promisemed Safety Huber Needles
    K243332 Promisemed Safety Huber Needles
    K243806 Safety Winged Blood Collection Sets
    K240675 Endoscopic Injection Needles
    K242632 Verifine® Pen Needles
    K234124 Single Use Hemoclips
    K231792 VeriSafe Safety sterile syringes
    K230715 Promisemed Safety Huber Needle
    K223453 Insulin Syringe
    Search all 31 clearances from Promisemed Hangzhou Meditech Co., Ltd. →