SIGNA Bolt
K-Number: K253780 · 2026-02-06
ApplicantGe Medical Systems, LLC
Decision Date2026-02-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SIGNA Bolt is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2026-02-06 under approval number K253780. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SIGNA Bolt?
SIGNA Bolt is a medical device that received FDA 510(k) clearance on 2026-02-06. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K253780.
When was SIGNA Bolt approved by the FDA?
SIGNA Bolt received FDA 510(k) clearance on 2026-02-06, under approval number K253780.
What company makes SIGNA Bolt?
SIGNA Bolt is manufactured by Ge Medical Systems, LLC.
What is the FDA product code for SIGNA Bolt?
The FDA product code for SIGNA Bolt is LNH.
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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.