FDA 510(k)

Spectricept Skin and Wound Cleanser

Número K: K243875 · 2025-04-21

Data da decisão2025-04-21

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Spectricept Skin and Wound Cleanser is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Antimicrobials, Inc.. It received FDA 510(k) clearance on 2025-04-21 under 510(k) number K243875. 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 Spectricept Skin and Wound Cleanser?

Spectricept Skin and Wound Cleanser is a medical device that received FDA 510(k) clearance on 2025-04-21. The listed applicant is Spectrum Antimicrobials, Inc.. The 510(k) number is K243875.

When did Spectricept Skin and Wound Cleanser receive FDA 510(k) clearance?

Spectricept Skin and Wound Cleanser received FDA 510(k) clearance on 2025-04-21, under 510(k) number K243875.

Who is the listed applicant for Spectricept Skin and Wound Cleanser?

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

What is the FDA product code for Spectricept Skin and Wound Cleanser?

The FDA product code for Spectricept Skin and Wound Cleanser is FRO. This falls under the Anesthesiology category.

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