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FDA 510(k)

Silverwear Silver Pro Garment Device

K-Number: K171798 · 2018-06-01

ApplicantMedia Plus, LLC
Decision Date2018-06-01
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Silverwear Silver Pro Garment Device is a medical device manufactured by Media Plus, LLC. It received FDA 510(k) clearance on 2018-06-01 under approval number K171798. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Silverwear Silver Pro Garment Device?

Silverwear Silver Pro Garment Device is a medical device that received FDA 510(k) clearance on 2018-06-01. It is manufactured by Media Plus, LLC. The 510(k) number is K171798.

When was Silverwear Silver Pro Garment Device approved by the FDA?

Silverwear Silver Pro Garment Device received FDA 510(k) clearance on 2018-06-01, under approval number K171798.

What company makes Silverwear Silver Pro Garment Device?

Silverwear Silver Pro Garment Device is manufactured by Media Plus, LLC.

What is the FDA product code for Silverwear Silver Pro Garment Device?

The FDA product code for Silverwear Silver Pro Garment Device is GXY.

Related Clinical Trials

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Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025)

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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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