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

    PORGES HOT BIOPSY FORCEPS

    K Number: K896537 · Decision Nov 30, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    45
    Applicant Total
    18
    Review Days
    15

    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
    PORGES HOT BIOPSY FORCEPS
    K Number
    K896537
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Porges Corp.
    Date Received
    November 15, 1989
    Decision Date
    November 30, 1989
    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 Porges Corp.

    K Number Device Name
    K900269 PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE
    K900031 MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS
    K896503 PORGES ERCP CATHETERS
    K896505 PORGES UNIVERSAL HANDLES
    K896425 PORGES CYTOLOGY BRUSHES
    K896507 PORGES DIATHERMY SNARE
    K896504 PORGES 2-WAY BALLOON EXTRACTION CATHETER
    K896424 PORGES SCLEROTHERAPY NEEDLES
    K896506 PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTOR
    K896423 PORGES BILIARY STENTS
    Search all 18 clearances from Porges Corp. →