FDA 510(k)

ReNew Disposable Scissor Tips

K号: K213127 · 2022-03-02

决定日期2022-03-02

产品代码GEI

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决定实质等同

器械摘要

ReNew Disposable Scissor Tips 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 2022-03-02 under 510(k) number K213127. 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 Disposable Scissor Tips?

ReNew Disposable Scissor Tips is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Microline Surgical, Inc.. The 510(k) number is K213127.

When did ReNew Disposable Scissor Tips receive FDA 510(k) clearance?

ReNew Disposable Scissor Tips received FDA 510(k) clearance on 2022-03-02, under 510(k) number K213127.

Who is the listed applicant for ReNew Disposable Scissor Tips?

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 Disposable Scissor Tips?

The FDA product code for ReNew Disposable Scissor Tips 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）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 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。

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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