FDA 510(k)

Aesculap Caiman 5 密封和切割技术系统

K号: K202938 · 2020-10-30

决定日期2020-10-30

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

Aesculap Caiman 5 Seal and Cut Technology System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2020-10-30 under 510(k) number K202938. 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 Aesculap Caiman 5 Seal and Cut Technology System?

Aesculap Caiman 5 Seal and Cut Technology System is a medical device that received FDA 510(k) clearance on 2020-10-30. The listed applicant is Aesculap, Inc.. The 510(k) number is K202938.

When did Aesculap Caiman 5 Seal and Cut Technology System receive FDA 510(k) clearance?

Aesculap Caiman 5 Seal and Cut Technology System received FDA 510(k) clearance on 2020-10-30, under 510(k) number K202938.

Who is the listed applicant for Aesculap Caiman 5 Seal and Cut Technology System?

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

What is the FDA product code for Aesculap Caiman 5 Seal and Cut Technology System?

The FDA product code for Aesculap Caiman 5 Seal and Cut Technology System is GEI.

列明Aesculap, 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。

K242762Aesculap Aicon® 系列容器系统 K242003XABO 室间隔导管，XABO 腹膜导管，XABO 导管套装 K223596SQ.line KERRISON K214041Aesculap AICON 容器 K211572Aesculap Slim Clip Applier K203739ELAN 4 电动电机系统

查看所有 34 个设备 →

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。