FT10 Vessel Sealing Generator

FT10 Vessel Sealing Generator
Valleylab - VLFT10LSGEN

An electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OCL

Device Name: Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Device Class: 2

Physical State: The device tip delivers energy to provide cutting, coagulation, and/or ablation of the contacted tissue

Definition: Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device energy source used to provide cutting, coagulation and/or ablation may be radio frequency (RF), cryogenic, laser or ultrasound

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Cardiac tissue.

Regulation Number: 878.4400

Third Party Flag: Y

Medical Specialty: SU

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 Id: 10884521829534

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