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FDA 510(k)

Antimicrobial Gelling Fiber Dressing with PHMB

K-Number: K213473 · 2023-10-26

ApplicantAdvanced Medical Solutions, Ltd.
Decision Date2023-10-26
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Antimicrobial Gelling Fiber Dressing with PHMB is a medical device manufactured by Advanced Medical Solutions, Ltd.. It received FDA 510(k) clearance on 2023-10-26 under approval number K213473. 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 Antimicrobial Gelling Fiber Dressing with PHMB?

Antimicrobial Gelling Fiber Dressing with PHMB is a medical device that received FDA 510(k) clearance on 2023-10-26. It is manufactured by Advanced Medical Solutions, Ltd.. The 510(k) number is K213473.

When was Antimicrobial Gelling Fiber Dressing with PHMB approved by the FDA?

Antimicrobial Gelling Fiber Dressing with PHMB received FDA 510(k) clearance on 2023-10-26, under approval number K213473.

What company makes Antimicrobial Gelling Fiber Dressing with PHMB?

Antimicrobial Gelling Fiber Dressing with PHMB is manufactured by Advanced Medical Solutions, Ltd..

What is the FDA product code for Antimicrobial Gelling Fiber Dressing with PHMB?

The FDA product code for Antimicrobial Gelling Fiber Dressing with PHMB is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

NCT05741866 Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs) COMPLETED NCT07494773 Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection NOT_YET_RECRUITING NCT07066254 The Mepilex Cesarean Delivery Trial NOT_YET_RECRUITING

Other Devices by Advanced Medical Solutions, Ltd.

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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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