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FDA 510(k)

Plasma Shield

K-Number: K221533 · 2022-09-12

ApplicantPlasmatica, Ltd.
Decision Date2022-09-12
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Plasma Shield is the device name listed in this FDA 510(k) record. The listed applicant is Plasmatica, Ltd.. It received FDA 510(k) clearance on 2022-09-12 under 510(k) number K221533. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Plasma Shield?

Plasma Shield is a medical device that received FDA 510(k) clearance on 2022-09-12. The listed applicant is Plasmatica, Ltd.. The 510(k) number is K221533.

When did Plasma Shield receive FDA 510(k) clearance?

Plasma Shield received FDA 510(k) clearance on 2022-09-12, under 510(k) number K221533.

Who is the listed applicant for Plasma Shield?

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

What is the FDA product code for Plasma Shield?

The FDA product code for Plasma Shield is GCJ.

Related Devices (Code: GCJ)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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