Laproscopic Curved Spatula Electrode


Product Overview

Laproscopic Curved Spatula Electrode
CleanCoat - E3771-36C


Device Description

A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.


Environmental Conditions

  • Handling Environment Temperature - Degrees Fahrenheit
    • 149.00
    • -29.00
  • Special Storage Condition, Specify
    • Keep Dry
  • Storage Environment Temperature - Degrees Fahrenheit
    • 73.00
    • N/A

  • Device Sizes

  • Length: 36 Centimeter
    • Length: 36 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GEI

    Device Name: Electrosurgical, Cutting & Coagulation & Accessories

    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: SU

    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: 878.4400

    Third Party Flag: Y

    Medical Specialty: SU


    Device Identifiers

    Device Id: 20884521550770

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884521550773

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: PACK_OR_INNER_PACK


    Device Id: 10884521550773

    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


    Device Id: 30884521550777

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 20884521550770

    Package Quantity: 25

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CASE


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