CAVITY 8 GAUGE

CAVITY 8 GAUGE
Coblation - KP-CAV-7705-01

A sterile electrical conductor comprised of an electrode handpiece with cables and an active electrode, typically non-detachable, intended to provide an electrical connection between the output terminals of an electrosurgical diathermy generator and a patient. The energy emitted from the device is used to cut and coagulate tissue at a surgical site on the patient. The operator regulates the energy with a foot-switch. This is a non-dedicated device intended to be used in multiple clinical specialties. This is a single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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: 00817470004236

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