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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 a medical device manufactured by Advanced Medical Solutions, Ltd.. It received FDA 510(k) clearance on 2021-05-12 under approval 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. It is manufactured by Advanced Medical Solutions, Ltd.. The 510(k) number is K210974.

When was High Performance Antimicrobial Gelling Fiber with Silver approved by the FDA?

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

What company makes High Performance Antimicrobial Gelling Fiber with Silver?

High Performance Antimicrobial Gelling Fiber with Silver is manufactured by Advanced Medical Solutions, Ltd..

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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Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025)

Other Devices by Advanced Medical Solutions, Ltd.

K163062PHMB Antimicrobial Foam Wound Dressing K180634Surgical Silver Post Operative Dressing K181197PHMB Foam Wound Dressing K190819Silicone PHMB Foam Wound Dressing K183645Silver High Performance Dressing K213473Antimicrobial Gelling Fiber Dressing with PHMB

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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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