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FDA 510(k)

InSee

K-Number: K241152 · 2025-08-21

ApplicantTidal Medical Technologies, LLC
Decision Date2025-08-21
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

InSee is a medical device manufactured by Tidal Medical Technologies, LLC. It received FDA 510(k) clearance on 2025-08-21 under approval number K241152. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InSee?

InSee is a medical device that received FDA 510(k) clearance on 2025-08-21. It is manufactured by Tidal Medical Technologies, LLC. The 510(k) number is K241152.

When was InSee approved by the FDA?

InSee received FDA 510(k) clearance on 2025-08-21, under approval number K241152.

What company makes InSee?

InSee is manufactured by Tidal Medical Technologies, LLC.

What is the FDA product code for InSee?

The FDA product code for InSee is BWF.

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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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