Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SilverCeuticals® Antimicrobial Wound Gel

K-Number: K251929 · 2026-06-24

ApplicantSilverceuticals, Inc.
Decision Date2026-06-24
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SilverCeuticals® Antimicrobial Wound Gel is the device name listed in this FDA 510(k) record. The listed applicant is Silverceuticals, Inc.. It received FDA 510(k) clearance on 2026-06-24 under 510(k) number K251929. 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 SilverCeuticals® Antimicrobial Wound Gel?

SilverCeuticals® Antimicrobial Wound Gel is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Silverceuticals, Inc.. The 510(k) number is K251929.

When did SilverCeuticals® Antimicrobial Wound Gel receive FDA 510(k) clearance?

SilverCeuticals® Antimicrobial Wound Gel received FDA 510(k) clearance on 2026-06-24, under 510(k) number K251929.

Who is the listed applicant for SilverCeuticals® Antimicrobial Wound Gel?

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

What is the FDA product code for SilverCeuticals® Antimicrobial Wound Gel?

The FDA product code for SilverCeuticals® Antimicrobial Wound Gel 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.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.K254191IWD-Gel™InnovaCorium, 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.

↑