Ablatherm Fusion
K-Number: K172285 · 2017-10-03
ApplicantEdap Technomed, Inc.
Decision Date2017-10-03
Product CodePLP
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Ablatherm Fusion is a medical device manufactured by Edap Technomed, Inc.. It received FDA 510(k) clearance on 2017-10-03 under approval 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. It is manufactured by Edap Technomed, Inc.. The 510(k) number is K172285.
When was Ablatherm Fusion approved by the FDA?
Ablatherm Fusion received FDA 510(k) clearance on 2017-10-03, under approval number K172285.
What company makes Ablatherm Fusion?
Ablatherm Fusion is manufactured by Edap Technomed, Inc..
What is the FDA product code for Ablatherm Fusion?
The FDA product code for Ablatherm Fusion is PLP.
Other Devices by Edap Technomed, Inc.
Related Devices (Code: PLP)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.