FDA 510(k)

ReNew XR 手柄，ReNew XR 手柄 34cm，ReNew XR 手柄 42cm，ReNew XR 手柄 25cm，可调节式 ReNew XR 手柄 34cm

K号: K201884 · 2020-10-21

决定日期2020-10-21

产品代码GEI

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决定实质等同

器械摘要

ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm is the device name listed in this FDA 510(k) record. The listed applicant is Microline Surgical, Inc.. It received FDA 510(k) clearance on 2020-10-21 under 510(k) number K201884. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm?

ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is Microline Surgical, Inc.. The 510(k) number is K201884.

When did ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm receive FDA 510(k) clearance?

ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm received FDA 510(k) clearance on 2020-10-21, under 510(k) number K201884.

Who is the listed applicant for ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm?

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

What is the FDA product code for ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm?

The FDA product code for ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm is GEI.

列明Microline Surgical, 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。

K234147ReNew XR 手持件，25cm，带有参考标记（3943M）；ReNew XR 手持件，34cm，带有参考标记（3941M）；ReNew XR 手持件，42cm，带有参考标记（3942M）；ReNew XR 手持件，可调节，25cm，带有参考标记（3946M）；ReNew XR 手持件，可调节，34cm，带有参考标记（3944M）；ReNew XR 手持件，可调节，42cm，带有参考标记（3945M）K213127ReNew Disposable Scissor Tips K160706ReNew V 手持件腹腔镜器械 K152745ReNew Sterilization Trays(目录编号 #3708 和 #3709)K152743M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)

相关器械（代码：GEI）

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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