BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0

    K Number: K032822 · Decision Jan 8, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    161
    Applicant Total
    5
    Review Days
    120

    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
    ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0
    K Number
    K032822
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4760
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Asap Endoscopic Products GmbH
    Date Received
    September 10, 2003
    Decision Date
    January 8, 2004
    Product Code
    EOB
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EOB Nasopharyngoscope (Flexible Or Rigid)

    Similar 510(k) Clearances

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

    Hydro Irrigation System

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ENTity USB Videoscope System

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Outlook Surgical Versa One System (8900139)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Portare System (FA-001)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Asap Endoscopic Products GmbH

    K Number Device Name
    K121261 ASAP MUITISCOPE
    K031974 ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0
    K031972 ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,
    K031141 ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE