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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 a medical device manufactured by Twinsight. It received FDA 510(k) clearance on 2025-08-29 under approval 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. It is manufactured by Twinsight. The 510(k) number is K250290.

When was SurgiTwin approved by the FDA?

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

What company makes SurgiTwin?

SurgiTwin is manufactured by Twinsight.

What is the FDA product code for SurgiTwin?

The FDA product code for SurgiTwin is LLZ.

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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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