FDA 510(k)

高性能抗菌凝胶纤维（含银）

K号: K210974 · 2021-05-12

决定日期2021-05-12

产品代码FRO

决定实质等同

器械摘要

High Performance Antimicrobial Gelling Fiber with Silver is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Solutions, Ltd.. It received FDA 510(k) clearance on 2021-05-12 under 510(k) number K210974. 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 High Performance Antimicrobial Gelling Fiber with Silver?

High Performance Antimicrobial Gelling Fiber with Silver is a medical device that received FDA 510(k) clearance on 2021-05-12. The listed applicant is Advanced Medical Solutions, Ltd.. The 510(k) number is K210974.

When did High Performance Antimicrobial Gelling Fiber with Silver receive FDA 510(k) clearance?

High Performance Antimicrobial Gelling Fiber with Silver received FDA 510(k) clearance on 2021-05-12, under 510(k) number K210974.

Who is the listed applicant for High Performance Antimicrobial Gelling Fiber with Silver?

The FDA 510(k) record lists Advanced Medical Solutions, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for High Performance Antimicrobial Gelling Fiber with Silver?

The FDA product code for High Performance Antimicrobial Gelling Fiber with Silver is FRO. This falls under the Anesthesiology category.

列明Advanced Medical Solutions, 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。

K213473含PHMB的抗菌凝胶纤维敷料 K190819硅胶PHMB泡沫伤口敷料 K183645高性能银敷料 K180634外科银质术后敷料 K181197PHMB 泡沫伤口敷料 K163062PHMB 抗菌泡沫伤口敷料

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。