FDA 510(k)

Trabis

K-Number: K173893 · 2018-09-06

Decision Date2018-09-06

Product CodePLR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Trabis is the device name listed in this FDA 510(k) record. The listed applicant is Coligne AG. It received FDA 510(k) clearance on 2018-09-06 under 510(k) 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. The listed applicant is Coligne AG. The 510(k) number is K173893.

When did Trabis receive FDA 510(k) clearance?

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

Who is the listed applicant for Trabis?

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

What is the FDA product code for Trabis?

The FDA product code for Trabis is PLR.

Other records listing Coligne AG as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.