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FDA 510(k)

Silverlon® Wound Contact, Burn Contact Dressing

K-Number: K241225 · 2024-07-31

ApplicantArgentum Medical, LLC
Decision Date2024-07-31
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Silverlon® Wound Contact, Burn Contact Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Argentum Medical, LLC. It received FDA 510(k) clearance on 2024-07-31 under 510(k) number K241225. 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 Silverlon® Wound Contact, Burn Contact Dressing?

Silverlon® Wound Contact, Burn Contact Dressing is a medical device that received FDA 510(k) clearance on 2024-07-31. The listed applicant is Argentum Medical, LLC. The 510(k) number is K241225.

When did Silverlon® Wound Contact, Burn Contact Dressing receive FDA 510(k) clearance?

Silverlon® Wound Contact, Burn Contact Dressing received FDA 510(k) clearance on 2024-07-31, under 510(k) number K241225.

Who is the listed applicant for Silverlon® Wound Contact, Burn Contact Dressing?

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

What is the FDA product code for Silverlon® Wound Contact, Burn Contact Dressing?

The FDA product code for Silverlon® Wound Contact, Burn Contact Dressing is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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.

NCT07453927Blue Light for Donor Site Healing in Burn PatientsRECRUITINGNCT07494773Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound InfectionNOT_YET_RECRUITINGNCT07607366Effects of Negative Pressure Wound Bandaging After MastectomyRECRUITINGNCT07740980Virtual Reality for Pain and Fear in Children With BurnsNOT_YET_RECRUITING

Other records listing Argentum Medical, LLC as applicant

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.

K221218Silverlon Wound Contact, Burn Contact DressingsK190343Silverlon Wound Contact, Burn Contact DressingsK180570Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)

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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