Empower RF Catheter 10010

GUDID 00856571007241

The EMPOWER RF Catheter is a monopolar endoscopic tool that is used to deliver controlled radiofrequency (RF) energy to a target site within the upper airway or tracheobronchial tree when connected to a standard electrosurgical generator. The EMPOWER RF Catheter is inserted through the bronchoscope/extended working channel of 2.0 mm ID or greater to reach the target site.

BRONCUS MEDICAL INC.

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 00856571007241
• NIH Device Record Key: 16a1eb48-956f-4a3c-86fe-d0d86e35cc0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Empower RF Catheter
• Version Model Number: 10010
• Catalog Number: 10010
• Company DUNS: 078684808
• Company Name: BRONCUS MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 650-428-1600
• Email: customersupport@broncus.com

Device Dimensions

• Outer Diameter: 1.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856571007241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183240

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-11
• Device Publish Date: 2019-11-01

Devices Manufactured by BRONCUS MEDICAL INC.

• 00856571007296 - Archimedes Access Kit: 2021-10-12 A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy.
• 00856571007241 - Empower RF Catheter: 2019-11-11The EMPOWER RF Catheter is a monopolar endoscopic tool that is used to deliver controlled radiofrequency (RF) energy to a target site within the upper airway or tracheobronchial tree when connected to a standard electrosurgical generator. The EMPOWER RF Catheter is inserted through the bronchoscope/extended working channel of 2.0 mm ID or greater to reach the target site.
• 00856571007241 - Empower RF Catheter: 2019-11-11 The EMPOWER RF Catheter is a monopolar endoscopic tool that is used to deliver controlled radiofrequency (RF) energy to a target
• 00856571007036 - Archimedes System: 2019-05-23 Archimedes software is installed on a desktop computer used to plan procedures and navigate to targets in the lung. The Procedu
• 00856571007104 - Archimedes Planning System: 2019-05-23 Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning
• 00856571007128 - LungPoint Planning System, v3.2: 2019-05-23 LungPoint Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning
• 00856571007173 - LungPoint VBN System, V3.2: 2019-05-23 LungPoint VBN Software is software installed on a desktop computer used to plan procedures and navigate to targets in the lung.
• 00856571007227 - Archimedes Access Key: 2019-05-23 Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning
• 00856571007258 - Archimedes Access Key, 10-pack: 2019-05-23 Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning