Endorectal Probe

GUDID 03661690000342

The endorectal Probe is a primary component of 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 this 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.

EDAP-TMS FRANCE

Physical therapy ultrasound system

• Primary Device ID: 03661690000342
• NIH Device Record Key: 51d474b7-267c-4113-9842-3f6deaa54f3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endorectal Probe
• Version Model Number: TMS 253728
• Company DUNS: 383113362
• Company Name: EDAP-TMS FRANCE
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661690000342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251910

FDA Product Code

• PLP: High Intensity Ultrasound System For Prostate Tissue Ablation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-03
• Device Publish Date: 2026-01-26

Devices Manufactured by EDAP-TMS FRANCE

• 03661690000267 - Focal One: 2026-02-03 The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HI
• 03661690000342 - Endorectal Probe: 2026-02-03The endorectal Probe is a primary component of 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 this 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.
• 03661690000342 - Endorectal Probe: 2026-02-03 The endorectal Probe is a primary component of the Focal One system which is a computer-controlled medical device intended to pr
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