FiXcision
K-Number: K182664 · 2018-12-07
ApplicantAgency For Medical Innovations GmbH
Decision Date2018-12-07
Product CodeKOA
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
FiXcision is a medical device manufactured by Agency For Medical Innovations GmbH. It received FDA 510(k) clearance on 2018-12-07 under approval number K182664. The device is classified under product code KOA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FiXcision?
FiXcision is a medical device that received FDA 510(k) clearance on 2018-12-07. It is manufactured by Agency For Medical Innovations GmbH. The 510(k) number is K182664.
When was FiXcision approved by the FDA?
FiXcision received FDA 510(k) clearance on 2018-12-07, under approval number K182664.
What company makes FiXcision?
FiXcision is manufactured by Agency For Medical Innovations GmbH.
What is the FDA product code for FiXcision?
The FDA product code for FiXcision is KOA.
Other Devices by Agency For Medical Innovations GmbH
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.