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FDA 510(k)

Microstream CO2 NanoPod

K-Number: K213911 · 2022-07-29

ApplicantCovidien, LLC
Decision Date2022-07-29
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Microstream CO2 NanoPod is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2022-07-29 under 510(k) number K213911. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Microstream CO2 NanoPod?

Microstream CO2 NanoPod is a medical device that received FDA 510(k) clearance on 2022-07-29. The listed applicant is Covidien, LLC. The 510(k) number is K213911.

When did Microstream CO2 NanoPod receive FDA 510(k) clearance?

Microstream CO2 NanoPod received FDA 510(k) clearance on 2022-07-29, under 510(k) number K213911.

Who is the listed applicant for Microstream CO2 NanoPod?

The FDA 510(k) record lists Covidien, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microstream CO2 NanoPod?

The FDA product code for Microstream CO2 NanoPod is CCK.

Other records listing Covidien, LLC 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.

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Related Devices (Code: CCK)

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.