FDA 510(k)

BIOBRANE临时伤口敷料；BIOBRANE手套

K号: K242146 · 2024-12-17

决定日期2024-12-17

产品代码KGN

决定实质等同

器械摘要

BIOBRANE Temporary Wound Dressing; BIOBRANE Glove 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 2024-12-17 under 510(k) number K242146. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the BIOBRANE Temporary Wound Dressing; BIOBRANE Glove?

BIOBRANE Temporary Wound Dressing; BIOBRANE Glove is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K242146.

When did BIOBRANE Temporary Wound Dressing; BIOBRANE Glove receive FDA 510(k) clearance?

BIOBRANE Temporary Wound Dressing; BIOBRANE Glove received FDA 510(k) clearance on 2024-12-17, under 510(k) number K242146.

Who is the listed applicant for BIOBRANE Temporary Wound Dressing; BIOBRANE Glove?

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 BIOBRANE Temporary Wound Dressing; BIOBRANE Glove?

The FDA product code for BIOBRANE Temporary Wound Dressing; BIOBRANE Glove is KGN.

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。

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 K203716PICO 单次使用负压伤口治疗系统，PICO 7 单次使用负压伤口治疗系统，PICO 7Y 单次使用负压伤口治疗系统，PICO 14 单次使用负压伤口治疗系统

查看所有 21 个设备 →

相关器械（代码：KGN）

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。

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus 手术基质，1cc（CG-01AP）；Accelagen Plus 手术基质，3cc（CG-03AP）；Accelagen Plus 手术基质，5cc（CG-05AP）；Accelagen Plus 手术条带，125x25x2mm（CG-125X25AP）；Accelagen Plus 手术条带，250x25x2mm（CG-250X25AP）Berkeley Advanced Biomaterials K260596胶原蛋白伤口粉Ventris Medical K260669Endoform 皮肤模板Aroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.

官方来源

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