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FDA 510(k)

Medline Burn and Wound Dressing

K-Number: K173911 · 2018-07-19

ApplicantMedline Industries, Inc.
Decision Date2018-07-19
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Medline Burn and Wound Dressing is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2018-07-19 under approval number K173911. 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 Medline Burn and Wound Dressing?

Medline Burn and Wound Dressing is a medical device that received FDA 510(k) clearance on 2018-07-19. It is manufactured by Medline Industries, Inc.. The 510(k) number is K173911.

When was Medline Burn and Wound Dressing approved by the FDA?

Medline Burn and Wound Dressing received FDA 510(k) clearance on 2018-07-19, under approval number K173911.

What company makes Medline Burn and Wound Dressing?

Medline Burn and Wound Dressing is manufactured by Medline Industries, Inc..

What is the FDA product code for Medline Burn and Wound Dressing?

The FDA product code for Medline Burn and 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: 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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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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