FDA 510(k)

ReNew V 手持件腹腔镜器械

K号: K160706 · 2016-10-19

决定日期2016-10-19

产品代码GEI

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决定实质等同

器械摘要

ReNew V Handpiece Laparoscopic Instruments 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 2016-10-19 under 510(k) number K160706. 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 V Handpiece Laparoscopic Instruments?

ReNew V Handpiece Laparoscopic Instruments is a medical device that received FDA 510(k) clearance on 2016-10-19. The listed applicant is Microline Surgical, Inc.. The 510(k) number is K160706.

When did ReNew V Handpiece Laparoscopic Instruments receive FDA 510(k) clearance?

ReNew V Handpiece Laparoscopic Instruments received FDA 510(k) clearance on 2016-10-19, under 510(k) number K160706.

Who is the listed applicant for ReNew V Handpiece Laparoscopic Instruments?

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 V Handpiece Laparoscopic Instruments?

The FDA product code for ReNew V Handpiece Laparoscopic Instruments 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 K201884ReNew 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 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。

K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，推钮开关（0703-046-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，推钮开关，大批量非无菌（0703-046-102）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，旋转开关（0703-047-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，旋转开关，大批量非无菌（0703-047-102）Stryker Instruments K261070LigaSure™ RAS 马里兰州颚部血管封合/分割器，纳米涂层Covidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364艾利安谜团射频设备Ellian Corp K253859Scarlet Pro（Scarlet Pro）VIOL Co., Ltd.

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