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FDA 510(k)

Colibri Endoscopy System

K-Number: K192305 · 2020-02-27

Applicant3nt Medical , Ltd.
Decision Date2020-02-27
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Colibri Endoscopy System is a medical device manufactured by 3nt Medical , Ltd.. It received FDA 510(k) clearance on 2020-02-27 under approval number K192305. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Colibri Endoscopy System?

Colibri Endoscopy System is a medical device that received FDA 510(k) clearance on 2020-02-27. It is manufactured by 3nt Medical , Ltd.. The 510(k) number is K192305.

When was Colibri Endoscopy System approved by the FDA?

Colibri Endoscopy System received FDA 510(k) clearance on 2020-02-27, under approval number K192305.

What company makes Colibri Endoscopy System?

Colibri Endoscopy System is manufactured by 3nt Medical , Ltd..

What is the FDA product code for Colibri Endoscopy System?

The FDA product code for Colibri Endoscopy System is EOB.

Related Clinical Trials

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Other Devices by 3nt Medical , Ltd.

K1629163NT endoscopy system K181838Sinusway Dilation System K202727Peregrine Endoscopy System

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K153701ULYSS Multi View SinuscopeSopro-Comeg GmbH K153009ULTRA TelescopesOlympus Winter & Ibe GmbH K152531InstaClear Lens CleanerGyrus Acmi, Inc. K170453Medrobotics Flex Robotic SystemMedrobotics Corporation K161298ShenDa SinuscopeShenyang Shenda Endoscope Co., Ltd. K170285AED SinuscopeNational Advanced Endoscopy Devices, Inc.

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.

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