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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 the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.. It received FDA 510(k) clearance on 2023-01-13 under 510(k) 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. The listed applicant is Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.. The 510(k) number is K213514.

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

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

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

The FDA 510(k) record lists Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, 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.

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

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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