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FDA 510(k)

CO2mbiLED

K-Number: K201096 · 2020-06-23

Decision Date2020-06-23
Product CodeFCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CO2mbiLED is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2020-06-23 under 510(k) number K201096. The device is classified under product code FCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CO2mbiLED?

CO2mbiLED is a medical device that received FDA 510(k) clearance on 2020-06-23. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K201096.

When did CO2mbiLED receive FDA 510(k) clearance?

CO2mbiLED received FDA 510(k) clearance on 2020-06-23, under 510(k) number K201096.

Who is the listed applicant for CO2mbiLED?

The FDA 510(k) record lists Karl Storz Endoscopy America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2mbiLED?

The FDA product code for CO2mbiLED is FCX.

Other records listing Karl Storz Endoscopy America, Inc. 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.

View all 52 devices →

Related Devices (Code: FCX)

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.

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.