FDA 510(k)

GYNECARE TVT Abbrevo排尿系统；GYNECARE TVT闭孔排尿系统

K号: K181151 · 2018-08-10

决定日期2018-08-10

产品代码PWJ

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决定实质等同

器械摘要

GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2018-08-10 under 510(k) number K181151. The device is classified under product code PWJ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System?

GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System is a medical device that received FDA 510(k) clearance on 2018-08-10. The listed applicant is ETHICON, Inc.. The 510(k) number is K181151.

When did GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System receive FDA 510(k) clearance?

GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System received FDA 510(k) clearance on 2018-08-10, under 510(k) number K181151.

Who is the listed applicant for GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System?

The FDA 510(k) record lists ETHICON, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System?

The FDA product code for GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System is PWJ.

列明ETHICON, Inc.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。

K253394涂层 VICRYL™ (Polyglactin 910) Plus 抗菌缝合线 K252047STRATAFIX® 对称 PDS® Plus 无结组织控制装置 K253572STRATAFIX® 螺旋 PRONOVA® 单向无结组织控制装置 STRATAFIX® 螺旋 PRONOVA® 双向无结组织控制装置 K253852MONOCRYL™ Plus 抗菌多甘露聚糖 – 25（单丝），无菌合成可吸收缝合线 K252743STRATAFIX® 螺旋 PDS® Plus 无结组织控制装置；STRATAFIX® 螺旋 MONOCRYL® Plus 无结组织控制装置 K243897PDS™ Plus 抗菌 (聚二氧杂环己酮) 灭菌合成可吸收外科缝合线

查看所有 29 个设备 →

相关器械（代码：PWJ）

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。

K173019GYNECARE TVT可重复使用导引器，GYNECARE TVT可重复使用刚性导管导引器，GYNECARE TVT EXACT排尿系统套管ETHICON, Inc.K173162GYNECARE TVT腹部导引器和连接器，GYNECARE TVT可重复使用导引器，GYNECARE TVT可重复使用刚性导管导引器ETHICON, Inc.K172614Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, LeftCaldera Medical, Inc.K172565Advantage/Advantage Fit 输送装置，Lynx 输送装置，Obtryx 输送装置（弯曲 & Halo），Obtryx II 输送装置（弯曲 & Halo），Solyx SIS 输送装置Boston Scientific Corporation

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。