G-Bond Universal
K-Number: K251124 · 2025-10-02
ApplicantGC America, Inc.
Decision Date2025-10-02
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
G-Bond Universal is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2025-10-02 under approval number K251124. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the G-Bond Universal?
G-Bond Universal is a medical device that received FDA 510(k) clearance on 2025-10-02. It is manufactured by GC America, Inc.. The 510(k) number is K251124.
When was G-Bond Universal approved by the FDA?
G-Bond Universal received FDA 510(k) clearance on 2025-10-02, under approval number K251124.
What company makes G-Bond Universal?
G-Bond Universal is manufactured by GC America, Inc..
What is the FDA product code for G-Bond Universal?
The FDA product code for G-Bond Universal is KLE.
Other Devices by GC America, Inc.
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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.