FDA 510(k)

Colibrí System

K-Number: K220546 · 2022-10-05

Decision Date2022-10-05

Product CodeLON

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Colibrí System is a medical device manufactured by Copan Wasp Srl. It received FDA 510(k) clearance on 2022-10-05 under approval number K220546. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Colibrí System?

Colibrí System is a medical device that received FDA 510(k) clearance on 2022-10-05. It is manufactured by Copan Wasp Srl. The 510(k) number is K220546.

When was Colibrí System approved by the FDA?

Colibrí System received FDA 510(k) clearance on 2022-10-05, under approval number K220546.

What company makes Colibrí System?

Colibrí System is manufactured by Copan Wasp Srl.

What is the FDA product code for Colibrí System?

The FDA product code for Colibrí System is LON.

Other Devices by Copan Wasp Srl

K193138Colibri System K232756Colibrí K223245Colibrí K251511PhenoMATRIX

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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.