FDA 510(k)

Colibrí

K-Number: K232756 · 2023-12-27

Decision Date2023-12-27

Product CodeLON

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Colibrí is a medical device manufactured by Copan Wasp Srl. It received FDA 510(k) clearance on 2023-12-27 under approval number K232756. 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?

Colibrí is a medical device that received FDA 510(k) clearance on 2023-12-27. It is manufactured by Copan Wasp Srl. The 510(k) number is K232756.

When was Colibrí approved by the FDA?

Colibrí received FDA 510(k) clearance on 2023-12-27, under approval number K232756.

What company makes Colibrí?

Colibrí is manufactured by Copan Wasp Srl.

What is the FDA product code for Colibrí?

The FDA product code for Colibrí is LON.

Other Devices by Copan Wasp Srl

K193138Colibri System K220546Colibrí System 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.