- Physicians Office Resource

The Acessa ProVu Console
Acessa ProVu System - 7100

Device Description

An electrically-powered, noninvasive unit designed to: 1) generate electrical energy in the radio-frequency (RF) band, for the focal RF ablation of soft tissues (e.g., uterine fibroids) via laparoscopic approach; 2) track the location of an electrosurgical ablation probe with respect to real-time ultrasound images; and 3) provide optional tracking and ultrasound image overlay based on electromagnetic (EM) guidance. It is intended to connect to an electrosurgical ablation probe/catheter (not included), a laparoscopic ultrasound transducer, an electromagnetic surgical navigation generator, and a monitor (not included) to target the RF delivery.

Environmental Conditions

Handling Environment Temperature - Degrees Celsius

30.00
10.00

Storage Environment Temperature - Degrees Celsius

65.00
-34.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: HFG

Device Name: Coagulator, Laparoscopic, Unipolar (And Accessories)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OB

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: 884.4160

Third Party Flag: Y

Medical Specialty: OB

Device Identifiers

Device Id: 15420045515307

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

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