EndyMed Contour Handpiece
K-Number: K161199 · 2016-08-01
ApplicantEndymed Medical, Ltd.
Decision Date2016-08-01
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
EndyMed Contour Handpiece is a medical device manufactured by Endymed Medical, Ltd.. It received FDA 510(k) clearance on 2016-08-01 under approval number K161199. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EndyMed Contour Handpiece?
EndyMed Contour Handpiece is a medical device that received FDA 510(k) clearance on 2016-08-01. It is manufactured by Endymed Medical, Ltd.. The 510(k) number is K161199.
When was EndyMed Contour Handpiece approved by the FDA?
EndyMed Contour Handpiece received FDA 510(k) clearance on 2016-08-01, under approval number K161199.
What company makes EndyMed Contour Handpiece?
EndyMed Contour Handpiece is manufactured by Endymed Medical, Ltd..
What is the FDA product code for EndyMed Contour Handpiece?
The FDA product code for EndyMed Contour Handpiece is PBX.
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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.