BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇳 China

    LUOFUCON® Collagen Particles (Collagen Wound Dressing)

    K Number: K232796 · Decision Apr 25, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    22
    Review Days
    226

    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
    LUOFUCON® Collagen Particles (Collagen Wound Dressing)
    K Number
    K232796
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Huizhou Foryou Medical Devices Co., Ltd.
    Date Received
    September 12, 2023
    Decision Date
    April 25, 2024
    Product Code
    KGN
    Advisory Committee
    Unknown
    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
    KGN Wound Dressing With Animal-Derived Material(S)

    Similar 510(k) Clearances

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

    ECMT-100 WMD

    FDA 510(k)
    FDA Unclassified ·Unknown

    Catalyze

    FDA 510(k)
    FDA Unclassified ·Unknown

    Roosin Collagen Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    Roosin Collagen Powder

    FDA 510(k)
    FDA Unclassified ·Unknown

    MatriDerm

    FDA 510(k)
    FDA Unclassified ·Unknown

    Derma-Gide

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Huizhou Foryou Medical Devices Co., Ltd.

    K Number Device Name
    K250642 LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
    K240809 LUOFUCON® Silver Collagen Dressing
    K242856 LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)
    K240485 LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)
    K223360 LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing
    K221110 LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing
    K223359 LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing
    K213598 LUOFUCON Collagen Wound Dressing
    K211123 LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
    K210718 LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing
    Search all 22 clearances from Huizhou Foryou Medical Devices Co., Ltd. →