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

    BIOPSY FORCEPS, ELECTRIC

    K Number: K925361 · Decision Mar 29, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    45
    Applicant Total
    94
    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
    BIOPSY FORCEPS, ELECTRIC
    K Number
    K925361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    United States Endoscopy Group, Inc.
    Date Received
    October 22, 1992
    Decision Date
    March 29, 1993
    Product Code
    KGE
    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
    KGE Forceps, Biopsy, Electric

    Similar 510(k) Clearances

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

    Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR

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

    Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)

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

    ClearHemograsper

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

    Disposable Hot Biopsy Forceps

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

    Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI

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

    Bipolar Coagulation Foreceps

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

    Other Clearances by United States Endoscopy Group, Inc.

    K Number Device Name
    K192265 gi-4000 Electrosurgical Generator
    K200745 Lariat, Hot/Cold Snare
    K192059 Bio Guard Air/Water & Suction Valves
    K191559 AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM
    K182909 Roth Net Retriever Product Line
    K182258 AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm
    K173650 AquaShield System CO2- Fujifilm
    K172805 gi-4000 Electrosurgical Generator
    K163495 AdvanCE capsule endoscope delivery device
    K163492 Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear
    Search all 94 clearances from United States Endoscopy Group, Inc. →