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Ablatherm Fusion

by Edap Technomed, Inc.

510(k) K172285

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK172285 Date3 Oct 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
PLP
Device Class
Class II
Regulation
21 CFR Part 876.4340
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ablatherm Fusion is a High Intensity Ultrasound System For Prostate Tissue Ablation. It uses the same process and technology for delivering HIFU energy as the Ablatherm Integrated Imaging. The device also features a dedicated software allowing elastic fusion between MR images, biopsies locations, and ultrasound.

The Ablatherm Fusion is supplied by Edap Technomed, Inc. and has received FDA 510K clearance. It is classified as a device with a product code of PLP and is regulated under the regulation number 876.4340. The device is intended for use in Gastroenterology and Urology medical specialties.

Other devices from Edap Technomed Inc.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Ablatherm Fusion used for?

    The Ablatherm Fusion is used for prostate tissue ablation, utilizing High Intensity Focused Ultrasound (HIFU) energy to target and treat prostate tissue.

  • Is the Ablatherm Fusion a single-use device?

    The device description does not specify if the Ablatherm Fusion is single-use or reusable, but it is designed for use in medical specialties such as Gastroenterology and Urology.

  • What regulatory clearance has the Ablatherm Fusion received?

    The Ablatherm Fusion has received FDA 510K clearance, indicating it is substantially equivalent to a predicate device.

  • What medical specialties is the Ablatherm Fusion intended for?

    The Ablatherm Fusion is intended for use in Gastroenterology and Urology medical specialties.