FDA 510(k)

烟雾排放手指开关，带电外科铅笔的烟雾排放系统

K号: K200372 · 2020-11-30

申请人Modern Medical Equipment Manufacturing, Ltd.

决定日期2020-11-30

产品代码GEI

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil is the device name listed in this FDA 510(k) record. The listed applicant is Modern Medical Equipment Manufacturing, Ltd.. It received FDA 510(k) clearance on 2020-11-30 under 510(k) number K200372. 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 Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil?

Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil is a medical device that received FDA 510(k) clearance on 2020-11-30. The listed applicant is Modern Medical Equipment Manufacturing, Ltd.. The 510(k) number is K200372.

When did Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil receive FDA 510(k) clearance?

Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil received FDA 510(k) clearance on 2020-11-30, under 510(k) number K200372.

Who is the listed applicant for Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil?

The FDA 510(k) record lists Modern Medical Equipment Manufacturing, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil?

The FDA product code for Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil is GEI.

列明Modern Medical Equipment Manufacturing, Ltd.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。

K210315一次性手控单极镊子带烟雾抽吸，一次性手控双极镊子带烟雾抽吸，一次性手控单极镊子，一次性手控双极镊子 K211170一次性冲洗双极电缆 K192542足部控制电外科笔，推钮电外科笔，摇杆开关电外科笔，枪套，电极

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.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。