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FDA 510(k)

High Performance Antimicrobial Gelling Fiber with Silver

K-Number: K210974 · 2021-05-12

ApplicantAdvanced Medical Solutions, Ltd.
Decision Date2021-05-12
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

High Performance Antimicrobial Gelling Fiber with Silver is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Solutions, Ltd.. It received FDA 510(k) clearance on 2021-05-12 under 510(k) number K210974. 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 High Performance Antimicrobial Gelling Fiber with Silver?

High Performance Antimicrobial Gelling Fiber with Silver is a medical device that received FDA 510(k) clearance on 2021-05-12. The listed applicant is Advanced Medical Solutions, Ltd.. The 510(k) number is K210974.

When did High Performance Antimicrobial Gelling Fiber with Silver receive FDA 510(k) clearance?

High Performance Antimicrobial Gelling Fiber with Silver received FDA 510(k) clearance on 2021-05-12, under 510(k) number K210974.

Who is the listed applicant for High Performance Antimicrobial Gelling Fiber with Silver?

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

What is the FDA product code for High Performance Antimicrobial Gelling Fiber with Silver?

The FDA product code for High Performance Antimicrobial Gelling Fiber with Silver is FRO. This falls under the Anesthesiology category.

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Other records listing Advanced Medical Solutions, Ltd. as applicant

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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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