FocalPak - The Focalpak is the single use kit of consumables - EDAP-TMS FRANCE

Duns Number:383113362

Device Description: The Focalpak is the single use kit of consumables to support a single patient procedure us The Focalpak is the single use kit of consumables to support a single patient procedure using the Focal One system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.

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More Product Details

Catalog Number

EDP 901400

Brand Name

FocalPak

Version/Model Number

EDP 901400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K172721

Product Code Details

Product Code

PLP

Product Code Name

High Intensity Ultrasound System For Prostate Tissue Ablation

Device Record Status

Public Device Record Key

03241da6-ac08-4f70-800d-65c60cbce653

Public Version Date

March 12, 2021

Public Version Number

1

DI Record Publish Date

March 04, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EDAP-TMS FRANCE" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 15