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

    KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA

    K Number: K120898 · Decision Aug 3, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    142
    Review Days
    130

    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
    KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA
    K Number
    K120898
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Richard Wolf Medical Instruments Corp.
    Date Received
    March 26, 2012
    Decision Date
    August 3, 2012
    Product Code
    OTJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OTJ Laparoscopic Single Port Access Device

    Similar 510(k) Clearances

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

    Uni-port

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

    CORE-SPORT

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

    AFS Medical Sterile Single-Use Access Port System

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

    FMX314 Surgical Platform

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

    Endo Keeper

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

    ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE

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

    Other Clearances by Richard Wolf Medical Instruments Corp.

    K Number Device Name
    K151282 core nova Complete Operating Room Endoscopy
    K130423 THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525
    K121724 ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2
    K090776 MEGAPULSE LASER SYSTEM AND FIBERS
    K080617 POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES
    K080977 3 CCD ENDOCAM 5550
    K071292 VIEW MD OFFICE SYSTEM, MODEL 41066.5540
    K062720 S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES
    K051276 HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM
    K051176 FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066
    Search all 142 clearances from Richard Wolf Medical Instruments Corp. →