FDA 510(k)

SkinSmart Antimicrobial HydroGel

Número K: K254041 · 2026-09-11

Data da decisão2026-09-11

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

SkinSmart Antimicrobial HydroGel is the device name listed in this FDA 510(k) record. The listed applicant is Magic Science Supply, LLC. It received FDA 510(k) clearance on 2026-09-11 under 510(k) number K254041. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SkinSmart Antimicrobial HydroGel?

SkinSmart Antimicrobial HydroGel is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is Magic Science Supply, LLC. The 510(k) number is K254041.

When did SkinSmart Antimicrobial HydroGel receive FDA 510(k) clearance?

SkinSmart Antimicrobial HydroGel received FDA 510(k) clearance on 2026-09-11, under 510(k) number K254041.

Who is the listed applicant for SkinSmart Antimicrobial HydroGel?

The FDA 510(k) record lists Magic Science Supply, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SkinSmart Antimicrobial HydroGel?

The FDA product code for SkinSmart Antimicrobial HydroGel is FRO. This falls under the Anesthesiology category.

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