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FDA 510(k)

Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)

K号: K252167 · 2025-12-19

申请人Qingdao Bright Moon Biomedical Materials Co., Ltd.
决定日期2025-12-19
产品代码FRO
决定实质等同

器械摘要

Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Bright Moon Biomedical Materials Co., Ltd.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K252167. 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 Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)?

Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Qingdao Bright Moon Biomedical Materials Co., Ltd.. The 510(k) number is K252167.

When did Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) receive FDA 510(k) clearance?

Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) received FDA 510(k) clearance on 2025-12-19, under 510(k) number K252167.

Who is the listed applicant for Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)?

The FDA 510(k) record lists Qingdao Bright Moon Biomedical Materials Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)?

The FDA product code for Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) 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Qingdao Bright Moon Biomedical Materials 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。

K220673无菌银藻酸盐伤口敷料

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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