FDA 510(k)

HSW切除器械

K号: K173070 · 2018-06-08

决定日期2018-06-08

产品代码HIH

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决定实质等同

器械摘要

HSW Resection Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Henke-Sass, Wolf GmbH. It received FDA 510(k) clearance on 2018-06-08 under 510(k) number K173070. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HSW Resection Instruments?

HSW Resection Instruments is a medical device that received FDA 510(k) clearance on 2018-06-08. The listed applicant is Henke-Sass, Wolf GmbH. The 510(k) number is K173070.

When did HSW Resection Instruments receive FDA 510(k) clearance?

HSW Resection Instruments received FDA 510(k) clearance on 2018-06-08, under 510(k) number K173070.

Who is the listed applicant for HSW Resection Instruments?

The FDA 510(k) record lists Henke-Sass, Wolf GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HSW Resection Instruments?

The FDA product code for HSW Resection Instruments is HIH.

列明Henke-Sass, Wolf GmbH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。

K1713364.0mm可灭菌0° WL 302mm膀胱镜；4.0mm可灭菌0° WL 302mm宫腔镜；19 Fr.膀胱尿道镜套管；17-25 Fr.膀胱尿道镜套管桥

相关器械（代码：HIH）

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。

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