GFS Ultimate
K-Number: K162198 · 2016-11-18
ApplicantParcus Medical, LLC
Decision Date2016-11-18
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
GFS Ultimate is a medical device manufactured by Parcus Medical, LLC. It received FDA 510(k) clearance on 2016-11-18 under approval number K162198. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GFS Ultimate?
GFS Ultimate is a medical device that received FDA 510(k) clearance on 2016-11-18. It is manufactured by Parcus Medical, LLC. The 510(k) number is K162198.
When was GFS Ultimate approved by the FDA?
GFS Ultimate received FDA 510(k) clearance on 2016-11-18, under approval number K162198.
What company makes GFS Ultimate?
GFS Ultimate is manufactured by Parcus Medical, LLC.
What is the FDA product code for GFS Ultimate?
The FDA product code for GFS Ultimate is MBI.
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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.