FDA 510(k)

Ellusa 可重复使用中性板

K号: K222425 · 2022-09-08

决定日期2022-09-08

产品代码GEI

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决定实质等同

器械摘要

Ellusa Reusable Neutral Plates is the device name listed in this FDA 510(k) record. The listed applicant is Ellusa, LLC. It received FDA 510(k) clearance on 2022-09-08 under 510(k) number K222425. 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 Ellusa Reusable Neutral Plates?

Ellusa Reusable Neutral Plates is a medical device that received FDA 510(k) clearance on 2022-09-08. The listed applicant is Ellusa, LLC. The 510(k) number is K222425.

When did Ellusa Reusable Neutral Plates receive FDA 510(k) clearance?

Ellusa Reusable Neutral Plates received FDA 510(k) clearance on 2022-09-08, under 510(k) number K222425.

Who is the listed applicant for Ellusa Reusable Neutral Plates?

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

What is the FDA product code for Ellusa Reusable Neutral Plates?

The FDA product code for Ellusa Reusable Neutral Plates is GEI.

列明Ellusa, LLC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。

K222429Ellusa 可重复使用双极电缆 K202558Ellusa 双极电极 K202562Ellusa 发电机，Ellusa 三角锥尖端，Ellusa RF-Cobb 尖端，Ellusa SP-Pack 和尖端，Ellusa 尖端套装

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

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