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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 the device name listed in this FDA 510(k) record. The listed applicant is Tribusmed Beheer BV. It received FDA 510(k) clearance on 2025-03-31 under 510(k) 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. The listed applicant is Tribusmed Beheer BV. The 510(k) number is K242166.

When did TribusConnect receive FDA 510(k) clearance?

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

Who is the listed applicant for TribusConnect?

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

What is the FDA product code for TribusConnect?

The FDA product code for TribusConnect is QIH.

Related Devices (Code: QIH)

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.

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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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