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)

Silverlon Wound Contact, Burn Contact Dressings

K-Number: K190343 · 2019-07-18

ApplicantArgentum Medical, LLC
Decision Date2019-07-18
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Silverlon Wound Contact, Burn Contact Dressings 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 2019-07-18 under 510(k) number K190343. 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 Dressings?

Silverlon Wound Contact, Burn Contact Dressings is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is Argentum Medical, LLC. The 510(k) number is K190343.

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

Silverlon Wound Contact, Burn Contact Dressings received FDA 510(k) clearance on 2019-07-18, under 510(k) number K190343.

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

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 Dressings?

The FDA product code for Silverlon Wound Contact, Burn Contact Dressings 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.

NCT07607366Effects of Negative Pressure Wound Bandaging After MastectomyRECRUITING

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.

K241225Silverlon® Wound Contact, Burn Contact DressingK221218Silverlon 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.

↑