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

    ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018

    K Number: K021266 · Decision Sep 27, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    111
    Review Days
    158

    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
    ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018
    K Number
    K021266
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ethicon Endo-Surgery, Inc.
    Date Received
    April 22, 2002
    Decision Date
    September 27, 2002
    Product Code
    KNS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

    Similar 510(k) Clearances

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

    Sphincterotome

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Vanquish Water Vapor Ablation Device

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SureTome™ SW Sphincterotome with DomeTip

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    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. →