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FDA 510(k)

SurgiTwin

K-Number: K250290 · 2025-08-29

ApplicantTwinsight
Decision Date2025-08-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SurgiTwin is the device name listed in this FDA 510(k) record. The listed applicant is Twinsight. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K250290. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurgiTwin?

SurgiTwin is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Twinsight. The 510(k) number is K250290.

When did SurgiTwin receive FDA 510(k) clearance?

SurgiTwin received FDA 510(k) clearance on 2025-08-29, under 510(k) number K250290.

Who is the listed applicant for SurgiTwin?

The FDA 510(k) record lists Twinsight as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SurgiTwin?

The FDA product code for SurgiTwin is LLZ.

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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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