Colibri System
K-Number: K193138 · 2021-12-27
ApplicantCopan Wasp Srl
Decision Date2021-12-27
Product CodeQQV
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Colibri System is a medical device manufactured by Copan Wasp Srl. It received FDA 510(k) clearance on 2021-12-27 under approval 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. It is manufactured by Copan Wasp Srl. The 510(k) number is K193138.
When was Colibri System approved by the FDA?
Colibri System received FDA 510(k) clearance on 2021-12-27, under approval number K193138.
What company makes Colibri System?
Colibri System is manufactured by Copan Wasp Srl.
What is the FDA product code for Colibri System?
The FDA product code for Colibri System is QQV.
Other Devices by Copan Wasp Srl
Related Devices (Code: QQV)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.