LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K030380
    Device Name
    TISSUELINK SEALING FORCEPS, MODEL 1 21-202-1
    Manufacturer
    TISSUELINK MEDICAL, INC.
    Date Cleared
    2003-03-03

    (26 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TISSUELINK SEALING FORCEPS, MODEL 1 21-202-1

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TissueLink Sealing Forceps (Bipolar Forceps) is a sterile, single use bipolar electrosurgical device intended to be used in general and thoracic electrosurgical applications for coagulating, sealing and transecting tissue. It is intended for, but not limited to abdominal and thoracic surgery, laparoscopic procedures, endoscopic procedures and thoracoscopic procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)

    Device Description

    TissueLink Sealing Forceps, Model 1 21-202-1

    AI/ML Overview

    The provided document is a 510(k) summary for a device modification, focusing on regulatory approval for the TissueLink Sealing Forceps. It does not contain information about acceptance criteria, device performance testing, or study details. Therefore, I cannot extract the requested information from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1