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FDA 510(k)

MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)

K-Number: K180643 · 2018-11-23

ApplicantMedcu Technologies , Ltd.
Decision Date2018-11-23
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) is a medical device manufactured by Medcu Technologies , Ltd.. It received FDA 510(k) clearance on 2018-11-23 under approval number K180643. 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 MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)?

MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) is a medical device that received FDA 510(k) clearance on 2018-11-23. It is manufactured by Medcu Technologies , Ltd.. The 510(k) number is K180643.

When was MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) approved by the FDA?

MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) received FDA 510(k) clearance on 2018-11-23, under approval number K180643.

What company makes MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)?

MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) is manufactured by Medcu Technologies , Ltd..

What is the FDA product code for MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)?

The FDA product code for MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07040683 Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: A Multicentre Randomised Study RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT06312267 Reducing Wound Infections Using Bioelectric Wound Dressings ENROLLING_BY_INVITATION NCT07549737 Effectiveness of Silicone Superabsorbent Polymer Dressings for Chronic Wound Management COMPLETED NCT07066254 The Mepilex Cesarean Delivery Trial NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (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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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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