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FDA 510(k)

Colibrí

K-Number: K232756 · 2023-12-27

ApplicantCopan Wasp Srl
Decision Date2023-12-27
Product CodeLON
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Colibrí is the device name listed in this FDA 510(k) record. The listed applicant is Copan Wasp Srl. It received FDA 510(k) clearance on 2023-12-27 under 510(k) 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. The listed applicant is Copan Wasp Srl. The 510(k) number is K232756.

When did Colibrí receive FDA 510(k) clearance?

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

Who is the listed applicant for Colibrí?

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

What is the FDA product code for Colibrí?

The FDA product code for Colibrí is LON.

Other records listing Copan Wasp Srl as applicant

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.

K251511PhenoMATRIXK223245ColibríK220546Colibrí SystemK193138Colibri System

Related Devices (Code: LON)

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

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

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