Spectricept Skin and Wound Cleanser

FDA 510(k) K213514 · Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.

Substantially Equivalent

510(k) numberK213514

Submission

Device name
Spectricept Skin and Wound Cleanser
Applicant
Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.
Petaluma, CA, US
Received
November 2, 2021
Decision date
January 13, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRO – Dressing, Wound, Drug
Device class
Unclassified

Other 510(k)s with product code FRO

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K254041SkinSmart Antimicrobial HydroGelFRO · Traditional Magic Science Supply, LLC09/11/2026SE
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K253665Vashe Plus Antimicrobial SolutionFRO · Traditional Urgo Medical North America, LLC08/11/2026SE
K261023Microdacyn Wound Irrigation SolutionFRO · Traditional Sonoma Pharmaceuticals, Inc.06/24/2026SE
K251929SilverCeuticals® Antimicrobial Wound GelFRO · Traditional Silverceuticals, Inc.06/24/2026SE
K261638Bonvadis®FRO · Special Oneness Biotech Co., Ltd.06/17/2026SE
K254073StatSeal DiscFRO · Traditional Merit Medical Systems, Inc.05/13/2026SE
K254191IWD-Gel™FRO · Traditional InnovaCorium, Inc.04/07/2026SE
K252023MiraChlor Antimicrobial Wound SolutionFRO · Traditional Letus Corporation03/25/2026SE
K251999Promogran Prisma™ Collagen Matrix with ORC and SilverFRO · Traditional Solventum Germany GmbH03/13/2026SE

Questions and answers

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

Spectricept Skin and Wound Cleanser (K213514) received a 510(k) decision of Substantially Equivalent on January 13, 2023, 437 days after the submission was received.

What is the product code of K213514?

The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.