Precision IE 4K


Product Overview

Precision IE 4K - 0502-275-030


Device Description

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint (e.g., knee, shoulder, elbow). It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine structural damage to a joint, often from sports injuries. The arthroscope eyepiece is normally interfaced with a video camera. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 75.0 Millimeter
  • Diameter: 2.7 Millimeter
  • Angle: 30.0 degree
    • Length: 75.0 Millimeter
    • Diameter: 2.7 Millimeter
    • Angle: 30.0 degree


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: True

    Sterilization Methods:

  • Hydrogen Peroxide
    • Hydrogen Peroxide


    Product Codes

    Code: HRX

    Device Name: Arthroscope

    Device Class: 2

    Physical State: N/A

    Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 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: OR

    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: 888.1100

    Third Party Flag: Y

    Medical Specialty: OR


    Device Identifiers

    Device Id: 07613327416428

    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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