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FDA 510(k)

Algidex Ag Silver Alginate Wound Dressing

K-Number: K173072 · 2018-04-04

ApplicantDeroyal Industries, Inc.
Decision Date2018-04-04
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Algidex Ag Silver Alginate Wound Dressing is a medical device manufactured by Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2018-04-04 under approval number K173072. 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 Algidex Ag Silver Alginate Wound Dressing?

Algidex Ag Silver Alginate Wound Dressing is a medical device that received FDA 510(k) clearance on 2018-04-04. It is manufactured by Deroyal Industries, Inc.. The 510(k) number is K173072.

When was Algidex Ag Silver Alginate Wound Dressing approved by the FDA?

Algidex Ag Silver Alginate Wound Dressing received FDA 510(k) clearance on 2018-04-04, under approval number K173072.

What company makes Algidex Ag Silver Alginate Wound Dressing?

Algidex Ag Silver Alginate Wound Dressing is manufactured by Deroyal Industries, Inc..

What is the FDA product code for Algidex Ag Silver Alginate Wound Dressing?

The FDA product code for Algidex Ag Silver Alginate 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 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 NCT07494773 Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection 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)

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Related Devices (Code: FRO)

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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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