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

    ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY

    K Number: K110913 · Decision Sep 23, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    53
    Applicant Total
    5
    Review Days
    175

    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
    ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY
    K Number
    K110913
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endoscopic Technologies, Inc. D/B/A Estech
    Date Received
    April 1, 2011
    Decision Date
    September 23, 2011
    Product Code
    OCL
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

    Similar 510(k) Clearances

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

    Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)

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

    Isolator Synergy EnCapture Ablation System (EMH)

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

    Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)

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

    Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device

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

    AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE

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

    AtriCure Isolator® Synergy™ Surgical Ablation System

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

    Other Clearances by Endoscopic Technologies, Inc. D/B/A Estech

    K Number Device Name
    K113475 ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM
    K100224 ESTECH COBRA BIPOLSR II
    K091542 ESTECH EASYFLOW CANNULA WITH GUIDEWIRE
    K091350 ESTECH HAWKEYE INTRODUCER SYSTEMS