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

    MODIFIED SERIES 2100 ENDOSCOPES

    K Number: K912089 · Decision Aug 12, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    11
    Applicant Total
    8
    Review Days
    91

    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
    MODIFIED SERIES 2100 ENDOSCOPES
    K Number
    K912089
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Laser, Inc.
    Date Received
    May 13, 1991
    Decision Date
    August 12, 1991
    Product Code
    ODF
    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
    ODF Mini Endoscope, Gastroenterology-Urology

    Similar 510(k) Clearances

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

    MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE

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

    POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200

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

    SPYSCOPE ACCESS AND DELIVERY CATHETER

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

    SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR

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

    SPYGLASS DIRECT VISULATION PROBE

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

    5 STAR MEDICAL ENDOSCOPE

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

    Other Clearances by Medical Laser, Inc.

    K Number Device Name
    K913136 LASER ENDOSCOPE DISC DECOMPRESSION KITS
    K912265 MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000
    K912447 SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200
    K901464 MEDILASE SERIES 2200 ENDOSCOPE
    K900894 MEDILASE SERIES 2100 ENDOSCOPE
    K900380 MEDILASE 5010 ENDOSCOPE CONSOLE
    K895837 MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR