High Intensity Ultrasound System For Prostate Tissue Ablation

Device Code: 2107

Product Code(s): PLP

Definition: Prostate Tissue Ablation

Device Classification Information

• Device Type ID: 2107
• Device Name: High Intensity Ultrasound System For Prostate Tissue Ablation
• Physical State: The System Consists Of A Console, A Probe With Therapy Transducer(s), And Single Use Accessories.
• Technical Method: Uses High Intensity Ultrasound To Heat Target Tissue Within The Prostate Gland, Causing Coagulation Necrosis Of That Tissue.
• Target Area: The Prostate Gland
• Regulation Description: High Intensity Ultrasound System For Prostate Tissue Ablation.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Urology And Lithotripsy Devices Branch (ULDB)
• Submission Type: 510(k)
• CFR Regulation Number: 876.4340 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: PLP
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 2107
• Device: High Intensity Ultrasound System For Prostate Tissue Ablation
• Product Code: PLP
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: High Intensity Ultrasound System For Prostate Tissue Ablation.
• CFR Regulation Number: 876.4340 [🔎]

Premarket Reviews
Manufacturer	Decision
EDAP TECHNOMED
	SUBSTANTIALLY EQUIVALENT	3
EDAP TMS, FRANCE SA
	SUBSTANTIALLY EQUIVALENT	3
SONACARE MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
SONACARE MEDICAL, LLC.
	GRANTED	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Edap Technomed Inc.	II	Oct-26-2017

TPLC Last Update: 2019-04-02 20:06:09