FDA 510(k)

Colibri System

K-Number: K193138 · 2021-12-27

Decision Date2021-12-27

Product CodeQQV

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Colibri System 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 2021-12-27 under 510(k) number K193138. The device is classified under product code QQV. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Colibri System?

Colibri System is a medical device that received FDA 510(k) clearance on 2021-12-27. The listed applicant is Copan Wasp Srl. The 510(k) number is K193138.

When did Colibri System receive FDA 510(k) clearance?

Colibri System received FDA 510(k) clearance on 2021-12-27, under 510(k) number K193138.

Who is the listed applicant for Colibri System?

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 Colibri System?

The FDA product code for Colibri System is QQV.

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.

K251511PhenoMATRIX K232756Colibrí K223245Colibrí K220546Colibrí System

Related Devices (Code: QQV)

K222563BD Kiestra IdentifABecton, Dickinson and Company K223245ColibríCopan Wasp Srl K191964BD Kiestra IdentifABecton, Dickinson and Company

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.