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FDA 510(k)

Stainless Turbine

K-Number: K203791 · 2022-06-21

ApplicantNakanishi, Inc.
Decision Date2022-06-21
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Stainless Turbine is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2022-06-21 under 510(k) number K203791. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stainless Turbine?

Stainless Turbine is a medical device that received FDA 510(k) clearance on 2022-06-21. The listed applicant is Nakanishi, Inc.. The 510(k) number is K203791.

When did Stainless Turbine receive FDA 510(k) clearance?

Stainless Turbine received FDA 510(k) clearance on 2022-06-21, under 510(k) number K203791.

Who is the listed applicant for Stainless Turbine?

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

What is the FDA product code for Stainless Turbine?

The FDA product code for Stainless Turbine is EFB.

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Related Devices (Code: EFB)

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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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