FDA 510(k)

X-手术

K号: K171752 · 2017-10-17

决定日期2017-10-17

产品代码GEI

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决定实质等同

器械摘要

X-SURGE is the device name listed in this FDA 510(k) record. The listed applicant is Genicon, Inc.. It received FDA 510(k) clearance on 2017-10-17 under 510(k) number K171752. 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 X-SURGE?

X-SURGE is a medical device that received FDA 510(k) clearance on 2017-10-17. The listed applicant is Genicon, Inc.. The 510(k) number is K171752.

When did X-SURGE receive FDA 510(k) clearance?

X-SURGE received FDA 510(k) clearance on 2017-10-17, under 510(k) number K171752.

Who is the listed applicant for X-SURGE?

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

What is the FDA product code for X-SURGE?

The FDA product code for X-SURGE is GEI.

列明Genicon, 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。

K190168Aquas 探针 K181791SIMPLYSTRONG, SIMPLYEZEE K180836Genistrong K180579Ezee Retrieval K162059EZEE 检索

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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