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FDA 510(k)

Antimicrobial Silicone PHMB Foam Wound Dressing

K-Number: K223310 · 2023-04-05

ApplicantAdvanced Medical Solutions Limited
Decision Date2023-04-05
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Antimicrobial Silicone PHMB Foam Wound Dressing is a medical device manufactured by Advanced Medical Solutions Limited. It received FDA 510(k) clearance on 2023-04-05 under approval number K223310. 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 Silicone PHMB Foam Wound Dressing?

Antimicrobial Silicone PHMB Foam Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-04-05. It is manufactured by Advanced Medical Solutions Limited. The 510(k) number is K223310.

When was Antimicrobial Silicone PHMB Foam Wound Dressing approved by the FDA?

Antimicrobial Silicone PHMB Foam Wound Dressing received FDA 510(k) clearance on 2023-04-05, under approval number K223310.

What company makes Antimicrobial Silicone PHMB Foam Wound Dressing?

Antimicrobial Silicone PHMB Foam Wound Dressing is manufactured by Advanced Medical Solutions Limited.

What is the FDA product code for Antimicrobial Silicone PHMB Foam Wound Dressing?

The FDA product code for Antimicrobial Silicone PHMB Foam Wound Dressing is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07604636 Adjunctive Ozone Therapy for Residual Periodontal Pockets COMPLETED NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 40574448 [Research and Discussion on the Whole Lifecycle Supervision of Typical Class Ⅱ Wound Dressing Products]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Advanced Medical Solutions Limited

K183570LiquiBand Plus K211878LiquiBand XL PMA P220024Tissue adhesive internal use

Related Devices (Code: FRO)

K160695Talymed SuspensionMarine Polymer Technologies, Inc. K160872PolyPlex Wound DressingGlobal Health Solutions, LLC K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mLB.Braun Medical, Inc. K152533Xonrid GelHelsinn Healthcare SA K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation K161212Atteris Antimicrobial Skin ProtectantRochal Industries, LLC

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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