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FDA 510(k)

Venue Go

K-Number: K261668 · 2026-08-07

Decision Date2026-08-07
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Venue Go is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound and Primary care Diagnostics, LLC. It received FDA 510(k) clearance on 2026-08-07 under 510(k) number K261668. 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 Go?

Venue Go is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is GE Medical Systems Ultrasound and Primary care Diagnostics, LLC. The 510(k) number is K261668.

When did Venue Go receive FDA 510(k) clearance?

Venue Go received FDA 510(k) clearance on 2026-08-07, under 510(k) number K261668.

Who is the listed applicant for Venue Go?

The FDA 510(k) record lists GE Medical Systems Ultrasound and Primary care Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Venue Go?

The FDA product code for Venue Go is IYN.

Other records listing GE Medical Systems Ultrasound and Primary care Diagnostics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 64 devices →

Related Devices (Code: IYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.