FDA 510(k)

SIGNA Sprint Select

K-Number: K253779 · 2026-02-05

Decision Date2026-02-05

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SIGNA Sprint Select is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2026-02-05 under approval number K253779. 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 Sprint Select?

SIGNA Sprint Select is a medical device that received FDA 510(k) clearance on 2026-02-05. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K253779.

When was SIGNA Sprint Select approved by the FDA?

SIGNA Sprint Select received FDA 510(k) clearance on 2026-02-05, under approval number K253779.

What company makes SIGNA Sprint Select?

SIGNA Sprint Select is manufactured by Ge Medical Systems, LLC.

What is the FDA product code for SIGNA Sprint Select?

The FDA product code for SIGNA Sprint Select is LNH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.