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FDA 510(k)

Spectricept Skin and Wound Cleanser

K-Number: K213514 · 2023-01-13

ApplicantSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.
Decision Date2023-01-13
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Spectricept Skin and Wound Cleanser is a medical device manufactured by Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.. It received FDA 510(k) clearance on 2023-01-13 under approval number K213514. 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.

Frequently Asked Questions

What is the Spectricept Skin and Wound Cleanser?

Spectricept Skin and Wound Cleanser is a medical device that received FDA 510(k) clearance on 2023-01-13. It is manufactured by Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.. The 510(k) number is K213514.

When was Spectricept Skin and Wound Cleanser approved by the FDA?

Spectricept Skin and Wound Cleanser received FDA 510(k) clearance on 2023-01-13, under approval number K213514.

What company makes Spectricept Skin and Wound Cleanser?

Spectricept Skin and Wound Cleanser is manufactured by Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc..

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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Official Source

View on FDA Database →

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

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