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FDA 510(k)

TribusConnect

K-Number: K242166 · 2025-03-31

ApplicantTribusmed Beheer BV
Decision Date2025-03-31
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TribusConnect is a medical device manufactured by Tribusmed Beheer BV. It received FDA 510(k) clearance on 2025-03-31 under approval number K242166. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TribusConnect?

TribusConnect is a medical device that received FDA 510(k) clearance on 2025-03-31. It is manufactured by Tribusmed Beheer BV. The 510(k) number is K242166.

When was TribusConnect approved by the FDA?

TribusConnect received FDA 510(k) clearance on 2025-03-31, under approval number K242166.

What company makes TribusConnect?

TribusConnect is manufactured by Tribusmed Beheer BV.

What is the FDA product code for TribusConnect?

The FDA product code for TribusConnect is QIH.

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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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