Gem Flow Now (GEM2770-FN)
K-Number: K233394 · 2024-01-28
ApplicantSynovis Micro Companies Alliance
Decision Date2024-01-28
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Gem Flow Now (GEM2770-FN) is a medical device manufactured by Synovis Micro Companies Alliance. It received FDA 510(k) clearance on 2024-01-28 under approval number K233394. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Gem Flow Now (GEM2770-FN)?
Gem Flow Now (GEM2770-FN) is a medical device that received FDA 510(k) clearance on 2024-01-28. It is manufactured by Synovis Micro Companies Alliance. The 510(k) number is K233394.
When was Gem Flow Now (GEM2770-FN) approved by the FDA?
Gem Flow Now (GEM2770-FN) received FDA 510(k) clearance on 2024-01-28, under approval number K233394.
What company makes Gem Flow Now (GEM2770-FN)?
Gem Flow Now (GEM2770-FN) is manufactured by Synovis Micro Companies Alliance.
What is the FDA product code for Gem Flow Now (GEM2770-FN)?
The FDA product code for Gem Flow Now (GEM2770-FN) is IYN.
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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.