FDA 510(k)

Ablatherm Fusion

K-Number: K172285 · 2017-10-03

Decision Date2017-10-03

Product CodePLP

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Ablatherm Fusion is the device name listed in this FDA 510(k) record. The listed applicant is Edap Technomed, Inc.. It received FDA 510(k) clearance on 2017-10-03 under 510(k) number K172285. The device is classified under product code PLP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ablatherm Fusion?

Ablatherm Fusion is a medical device that received FDA 510(k) clearance on 2017-10-03. The listed applicant is Edap Technomed, Inc.. The 510(k) number is K172285.

When did Ablatherm Fusion receive FDA 510(k) clearance?

Ablatherm Fusion received FDA 510(k) clearance on 2017-10-03, under 510(k) number K172285.

Who is the listed applicant for Ablatherm Fusion?

The FDA 510(k) record lists Edap Technomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ablatherm Fusion?

The FDA product code for Ablatherm Fusion is PLP.

Other records listing Edap Technomed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.