BEUDAMED
    Product Code: EOX FDA class 2 21 CFR 874.4710

    Esophagoscope (Flexible Or Rigid)

    Ear, Nose, Throat

    The esophagoscope (flexible or rigid) is an endoscopic instrument used to visually examine the esophagus, typically for diagnostic assessment or therapeutic intervention such as foreign body removal. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is EOX, regulated under 21 CFR 874.4710 in the Ear, Nose, Throat specialty. If the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in the 510(k) submission.

    View on FDA
    510(k)s
    30
    FEI Numbers
    38
    Registration Numbers
    38
    Unique Applicants
    16
    Years Active
    47

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    Basic Information

    Product Code
    EOX
    Device Class
    FDA class 2
    Regulation Number
    874.4710
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 30 510(k) clearances via K numbers.

    K Number Device Name
    K233142 EndoSign® Cell collection device (ES-CYT-102)
    K230339 EsoCheck Cell Collection Device
    K223072 PENTAX Medical Video Esophagoscope EE17-J10
    K222366 EsoCheck Cell Collection Device
    K203450 EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
    K210137 EsoCheck Cell Collection Device
    K192523 CMOS Video Esophagoscope SSU
    K183262 EsoCheck CCD Cell Collection Device
    K182159 Strome-Blitzer Cytology Balloon
    K181292 PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor
    K181020 Cytosponge Cell Collection Device
    K152794 Cytosponge Cell Collection Device
    K142695 Cytosponge Cell Collection Device
    K131131 E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM
    K120702 E.G. SCAN II ESPHAGOSCOPE SYSTEM
    K111030 E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM
    K072088 FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS
    K071903 ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE
    K051972 KARL STORZ TRANS-NASAL ESOPHAGOSCOPE
    K031786 TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM
    K953849 PRISM ELECTROSCOPE
    K951424 M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM
    K951395 KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES
    K946331 KARL STORZ BOUGIES, SOUNDS, DILATORS
    K945237 KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE
    K943667 ESOPHAGOSCOPE AND ACCESSORIES
    K934193 CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST
    K911588 BRANDT ESOPHAGEAL CYTOLOGY BALLOON
    K892259 JESBERG ESOPHAGOSCOPE
    K760652 JESBERG ESOPHAGOSCOPES W/AUSTINETIC S S

    FEI Numbers

    This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.