FDA 510(k)

Stage

K-Number: K223079 · 2022-10-28

Decision Date2022-10-28

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Stage is the device name listed in this FDA 510(k) record. The listed applicant is Spintech, Inc.. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K223079. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stage?

Stage is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Spintech, Inc.. The 510(k) number is K223079.

When did Stage receive FDA 510(k) clearance?

Stage received FDA 510(k) clearance on 2022-10-28, under 510(k) number K223079.

Who is the listed applicant for Stage?

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

What is the FDA product code for Stage?

The FDA product code for Stage is LNH.

Other records listing Spintech, 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.

K212109Spin Care Disposable Protective Mask Level 3 K210843STAGE K201624Spin Care Disposable Protective Mask K173224SPIN-SWI

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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.