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FDA 510(k)

geko W-3

K-Number: K220327 · 2022-03-04

ApplicantFirstkind Limited
Decision Date2022-03-04
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

geko W-3 is the device name listed in this FDA 510(k) record. The listed applicant is Firstkind Limited. It received FDA 510(k) clearance on 2022-03-04 under 510(k) number K220327. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the geko W-3?

geko W-3 is a medical device that received FDA 510(k) clearance on 2022-03-04. The listed applicant is Firstkind Limited. The 510(k) number is K220327.

When did geko W-3 receive FDA 510(k) clearance?

geko W-3 received FDA 510(k) clearance on 2022-03-04, under 510(k) number K220327.

Who is the listed applicant for geko W-3?

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

What is the FDA product code for geko W-3?

The FDA product code for geko W-3 is IPF.

Other records listing Firstkind Limited 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: IPF)

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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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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