Flexible Laparoscopic Argon Electrode Coagulation Only

Flexible Laparoscopic Argon Electrode Coagulation Only
Valleylab - E3530-28

Device Description

An invasive, distal component of an inert gas-enhanced electrosurgical system intended to deliver electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] directly to tissues for cutting/coagulation/ablation during an endoscopic (including laparoscopic, arthroscopic) surgical procedure. It is a long thin device with no controls, typically designed as a coaxial arrangement of a monopolar electrode within a gas delivery tube/sleeve, which requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., rigid laparoscopic electrode, flexible endoscopic probe). This is a single-use device.

Environmental Conditions

Handling Environment Humidity - Percent (%) Relative Humidity

90.00
15.00

Handling Environment Temperature - Degrees Fahrenheit

140.00
-22.00

Special Storage Condition, Specify

Keep dry

Storage Environment Humidity - Percent (%) Relative Humidity

90.00
15.00

Storage Environment Temperature - Degrees Fahrenheit

104.00
50.00

Device Sizes

Length: 28 Centimeter

Length: 28 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: 30884521767922

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20884521767925

Package Quantity: 15

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 10884521767928

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: 20884521767925

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521767928

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: PACK_OR_INNER_PACK