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FDA 510(k)

Venue; Venue Go; Venue Fit; Venue Sprint

K-Number: K251322 · 2025-07-25

ApplicantGE Medical Systems Ultrasound and Primary Care Diagnostics
Decision Date2025-07-25
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Venue; Venue Go; Venue Fit; Venue Sprint is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2025-07-25 under approval number K251322. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Venue; Venue Go; Venue Fit; Venue Sprint?

Venue; Venue Go; Venue Fit; Venue Sprint is a medical device that received FDA 510(k) clearance on 2025-07-25. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K251322.

When was Venue; Venue Go; Venue Fit; Venue Sprint approved by the FDA?

Venue; Venue Go; Venue Fit; Venue Sprint received FDA 510(k) clearance on 2025-07-25, under approval number K251322.

What company makes Venue; Venue Go; Venue Fit; Venue Sprint?

Venue; Venue Go; Venue Fit; Venue Sprint is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.

What is the FDA product code for Venue; Venue Go; Venue Fit; Venue Sprint?

The FDA product code for Venue; Venue Go; Venue Fit; Venue Sprint is IYN.

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Related Devices (Code: IYN)

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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.

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