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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 a medical device manufactured by Seriously Clean, Ltd.. It received FDA 510(k) clearance on 2025-05-02 under approval 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. It is manufactured by Seriously Clean, Ltd.. The 510(k) number is K243457.

When was Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel approved by the FDA?

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

What company makes Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel?

Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is manufactured by Seriously Clean, Ltd..

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

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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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