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

    8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535

    K Number: K020276 · Decision Apr 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    111
    Review Days
    74

    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
    8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535
    K Number
    K020276
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ethicon Endo-Surgery, Inc.
    Date Received
    January 28, 2002
    Decision Date
    April 12, 2002
    Product Code
    NEU
    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
    NEU Marker, Radiographic, Implantable

    Similar 510(k) Clearances

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

    HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)

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

    MOLLI 2 System

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

    SCOUT MD Surgical Guidance System

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

    VizMark Preloaded Tissue Marker Device (VM-0001)

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

    MammoSTAR Biopsy Site Identifier

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

    UltraCor™ Twirl™ Breast Tissue Marker

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

    Other Clearances by Ethicon Endo-Surgery, Inc.

    K Number Device Name
    K141952 ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
    K111195 VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
    K110385 ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
    K101520 ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH
    K102632 ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
    K093896 ETHICON ENDO SURGERY SLOTTED ANOSCOPE
    K091259 ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS
    K091824 ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507
    K093236 ETHICON ENDO-SURGERYOPTICAL DILATOR
    K091290 ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508
    Search all 111 clearances from Ethicon Endo-Surgery, Inc. →