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FDA 510(k)

Trabis

K-Number: K173893 · 2018-09-06

ApplicantColigne AG
Decision Date2018-09-06
Product CodePLR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Trabis is a medical device manufactured by Coligne AG. It received FDA 510(k) clearance on 2018-09-06 under approval number K173893. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Trabis?

Trabis is a medical device that received FDA 510(k) clearance on 2018-09-06. It is manufactured by Coligne AG. The 510(k) number is K173893.

When was Trabis approved by the FDA?

Trabis received FDA 510(k) clearance on 2018-09-06, under approval number K173893.

What company makes Trabis?

Trabis is manufactured by Coligne AG.

What is the FDA product code for Trabis?

The FDA product code for Trabis is PLR.

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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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