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

    DERMABOND NX ADHESIVE MODEL: DNX6, DNX12

    K Number: K100423 · Decision May 4, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    35
    Applicant Total
    204
    Review Days
    77

    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
    DERMABOND NX ADHESIVE MODEL: DNX6, DNX12
    K Number
    K100423
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ETHICON, Inc.
    Date Received
    February 16, 2010
    Decision Date
    May 4, 2010
    Product Code
    MPN
    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
    MPN Tissue Adhesive For The Topical Approximation Of Skin

    Similar 510(k) Clearances

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

    BondEase 2 Topical Skin Adhesive

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CM005 Standard (CM005); CM004 Mini (CM004)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Meriglu Topical Skin Adhesive

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Exofin Precision Pen

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by ETHICON, Inc.

    K Number Device Name
    K252047 STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices
    K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device
    K253852 MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
    K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device
    K243897 PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
    K221744 STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device
    K212380 PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
    K213512 DERMABOND PRINEO Skin Closure System
    K201996 Monocryl Plus Antibacterial Suture
    K201686 GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide
    Search all 204 clearances from ETHICON, Inc. →