G aenial Universal Injectable II
K-Number: K251946 · 2025-08-29
ApplicantGC America, Inc.
Decision Date2025-08-29
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
G aenial Universal Injectable II is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2025-08-29 under approval number K251946. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the G aenial Universal Injectable II?
G aenial Universal Injectable II is a medical device that received FDA 510(k) clearance on 2025-08-29. It is manufactured by GC America, Inc.. The 510(k) number is K251946.
When was G aenial Universal Injectable II approved by the FDA?
G aenial Universal Injectable II received FDA 510(k) clearance on 2025-08-29, under approval number K251946.
What company makes G aenial Universal Injectable II?
G aenial Universal Injectable II is manufactured by GC America, Inc..
What is the FDA product code for G aenial Universal Injectable II?
The FDA product code for G aenial Universal Injectable II is EBF.
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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.