Precision S 4K


Product Overview

Precision S 4K - 0502-652-130


Device Description

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the nasal cavity and/or nasopharynx. It is inserted into the body through a nostril or the oral cavity during rhinoscopy or an ear/nose/throat (ENT) intervention. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. Also referred to as a nasoscope or nasal endoscope, it is typically used during the removal of the adenoids (glandular tissue in the nasopharynx, also known as the pharyngeal tonsils). This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 170.0 Millimeter
  • Angle: 30.0 degree
  • Diameter: 3.1 Millimeter
    • Length: 170.0 Millimeter
    • Angle: 30.0 degree
    • Diameter: 3.1 Millimeter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: True

    Sterilization Methods:

  • Moist Heat or Steam Sterilization
  • Hydrogen Peroxide
    • Moist Heat or Steam Sterilization
    • Hydrogen Peroxide


    Product Codes

    Code: EOB

    Device Name: Nasopharyngoscope (Flexible Or Rigid)

    Device Class: 2

    Physical State: N/A

    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).

    Submission Type ID: 1

    Review Panel: EN

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 874.4760

    Third Party Flag: Y

    Medical Specialty: EN


    Device Identifiers

    Device Id: 07613327412123

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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