Single Use Hot Biopsy Forceps FD-231

Single Use Hot Biopsy Forceps FD
Single Use Hot Biopsy Forceps FD-231 - FD-231C

A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. 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: KGE

Device Name: Forceps, Biopsy, Electric

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

Code: QEC

Device Name: Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree

Device Class: 2

Physical State: Electrosurgical forceps and may include accessories.

Definition: An endoscopic electrosurgical forceps and accessories used with an endoscope to electrosurgically collect tissue for biopsy and to perform electrosurgical hemostasis within the tracheobronchial tree

Submission Type ID: 1

Review Panel: AN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device is deployed through a bronchoscope.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Tracheobronchial tree.

Regulation Number: 876.4300

Third Party Flag: N

Medical Specialty: GU

Device Id: 14953170418676

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170418679

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 04953170418679

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