CORE-INJECTOR
K-Number: K221054 · 2022-12-21
ApplicantIncore Co., Ltd.
Decision Date2022-12-21
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
CORE-INJECTOR is a medical device manufactured by Incore Co., Ltd.. It received FDA 510(k) clearance on 2022-12-21 under approval number K221054. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CORE-INJECTOR?
CORE-INJECTOR is a medical device that received FDA 510(k) clearance on 2022-12-21. It is manufactured by Incore Co., Ltd.. The 510(k) number is K221054.
When was CORE-INJECTOR approved by the FDA?
CORE-INJECTOR received FDA 510(k) clearance on 2022-12-21, under approval number K221054.
What company makes CORE-INJECTOR?
CORE-INJECTOR is manufactured by Incore Co., Ltd..
What is the FDA product code for CORE-INJECTOR?
The FDA product code for CORE-INJECTOR is FBK.
Other Devices by Incore Co., Ltd.
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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.