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FDA 510(k)

Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel

K-Number: K243457 · 2025-05-02

ApplicantSeriously Clean, Ltd.
Decision Date2025-05-02
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is the device name listed in this FDA 510(k) record. The listed applicant is Seriously Clean, Ltd.. It received FDA 510(k) clearance on 2025-05-02 under 510(k) number K243457. 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 Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel?

Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is a medical device that received FDA 510(k) clearance on 2025-05-02. The listed applicant is Seriously Clean, Ltd.. The 510(k) number is K243457.

When did Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel receive FDA 510(k) clearance?

Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel received FDA 510(k) clearance on 2025-05-02, under 510(k) number K243457.

Who is the listed applicant for Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel?

The FDA 510(k) record lists Seriously Clean, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel?

The FDA product code for Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is FRO. This falls under the Anesthesiology category.

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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

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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