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FDA 510(k)

LUOFUCON® 硅胶银离子泡沫敷料（处方用药）/ LUOFUCON® 硅胶银离子抗菌泡沫敷料（非处方用药）(边缘型、边缘型轻便、无边缘型和转移型)

K号: K242856 · 2024-11-13

申请人Huizhou Foryou Medical Devices Co., Ltd.
决定日期2024-11-13
产品代码FRO
决定实质等同

器械摘要

LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2024-11-13 under 510(k) number K242856. 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.

常见问题

What is the LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)?

LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) is a medical device that received FDA 510(k) clearance on 2024-11-13. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K242856.

When did LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) receive FDA 510(k) clearance?

LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) received FDA 510(k) clearance on 2024-11-13, under 510(k) number K242856.

Who is the listed applicant for LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)?

FDA 510(k)记录将惠州友康医疗设备有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)?

The FDA product code for LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) is FRO. This falls under the Anesthesiology category.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Huizhou Foryou Medical Devices Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254256LUOFUCON® 创面基质K250642LUOFUCON® 皮肤和伤口清洁剂（喷雾、雾状、挤压、瓶装）K240809LUOFUCON® 银胶原敷料K240485LUOFUCON® 额外银凝胶纤维敷料 Plus（处方用药），LUOFUCON® 银抗菌凝胶纤维敷料 Plus（非处方用药）K232796LUOFUCON® 胶原颗粒（胶原蛋白伤口敷料）K223360LUOFUCON® 硅胶银离子泡沫敷料, LUOFUCON® 硅胶银离子抗菌泡沫敷料

查看所有 18 个设备 →

相关器械（代码：FRO）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254168Actolind®（06.3637. Actolind®凝胶加强型）ACTO GmbHK254041SkinSmart 抗菌保湿凝胶Magic Science Supply, LLCK261646Redermax® 抗菌伤口基质Beijing Kreate Medical Co., Ltd.K253665Vashe Plus 抗菌溶液Urgo Medical North America, LLCK251929SilverCeuticals® 抗菌伤口凝胶Silverceuticals, Inc.K261023Microdacyn 伤口冲洗溶液Sonoma Pharmaceuticals, Inc.

官方来源

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