FDA 510(k)

ACTICOAT 外科敷料

K号: K153723 · 2016-09-14

决定日期2016-09-14

产品代码FRO

决定实质等同

器械摘要

ACTICOAT Surgical Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2016-09-14 under 510(k) number K153723. 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 ACTICOAT Surgical Dressing?

ACTICOAT Surgical Dressing is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K153723.

When did ACTICOAT Surgical Dressing receive FDA 510(k) clearance?

ACTICOAT Surgical Dressing received FDA 510(k) clearance on 2016-09-14, under 510(k) number K153723.

Who is the listed applicant for ACTICOAT Surgical Dressing?

The FDA 510(k) record lists Smith & Nephew Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTICOAT Surgical Dressing?

The FDA product code for ACTICOAT Surgical Dressing is FRO. This falls under the Anesthesiology category.

列明Smith & Nephew Medical Limited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。

K242146BIOBRANE临时伤口敷料；BIOBRANE手套 K223526ALLEVYN Ag+边缘抗菌硅胶凝胶复合水合泡沫敷料，ALLEVYN Ag+骶骨抗菌硅胶凝胶复合水合泡沫敷料，ALLEVYN Ag+手术抗菌硅胶凝胶复合水合泡沫敷料 K220964VERSAJET 水刀手术系统（III）K213853RENASYS™-WF 白色泡沫 NPWT 敷料小号；RENASYS™-WF 白色泡沫 NPWT 敷料大号 K223041Renasys Edge (66803126)K202783Renasys-F XL 泡沫敷料套装，带软端口，Renasys XL 透明薄膜敷料

查看所有 21 个设备 →

官方来源

在 FDA 数据库中查看 →

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。