Semi-Flexible Scissors, 5 Fr.


Product Overview

Semi
NA - 0502555300


Device Description

A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 41.0 Centimeter
    • Length: 41.0 Centimeter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: True

    Sterilization Methods:

  • Moist Heat or Steam Sterilization
  • Ethylene Oxide
    • Moist Heat or Steam Sterilization
    • Ethylene Oxide


    Product Codes

    Code: KQT

    Device Name: Evacuator, Gastro-Urology

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: GU

    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: 876.4370

    Third Party Flag: N

    Medical Specialty: GU


    Code: HIH

    Device Name: Hysteroscope (And Accessories)

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: OB

    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: 884.1690

    Third Party Flag: Y

    Medical Specialty: OB


    Code: FAJ

    Device Name: Cystoscope And Accessories, Flexible/Rigid

    Device Class: 2

    Physical State: endoscope, accessories associated with cystoscope

    Definition: To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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: GU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Intrument guided through urethra for visualization and to perform various procedures.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: bladder, urethra, kidneys

    Regulation Number: 876.1500

    Third Party Flag: N

    Medical Specialty: GU


    Code: FAS

    Device Name: Electrode, Electrosurgical, Active, Urological

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: GU

    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: 876.4300

    Third Party Flag: Y

    Medical Specialty: GU


    Device Identifiers

    Device Id: 07613327059502

    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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