FDA 510(k)

狼人+ 碘化钠等离子体系统，狼人+ 控制器，狼人+ 快速密封 6.0 止血棒

K号: K210423 · 2021-06-24

决定日期2021-06-24

产品代码GEI

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决定实质等同

器械摘要

Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand is the device name listed in this FDA 510(k) record. The listed applicant is ArthroCare Corporation. It received FDA 510(k) clearance on 2021-06-24 under 510(k) number K210423. 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 Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand?

Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand is a medical device that received FDA 510(k) clearance on 2021-06-24. The listed applicant is ArthroCare Corporation. The 510(k) number is K210423.

When did Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand receive FDA 510(k) clearance?

Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand received FDA 510(k) clearance on 2021-06-24, under 510(k) number K210423.

Who is the listed applicant for Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand?

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

What is the FDA product code for Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand?

The FDA product code for Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand is GEI.

列明ArthroCare Corporation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。

K254122FLOW FLEXTEND Wand (72290039)K253680LYNX COBLATION Laryngeal Wand (72290254)K240964FLOW 90? Wand K232290INTELLIO SHIFT 系统 K230914ARIS¿ COBLATION¿ 鼻甲缩减棒（72290113）；WEREWOLF COBLATION 系统（72290144）；WEREWOLF+ COBLATION 系统（72290146）K220563Ambient HipVac 50 手杖带集成手指开关, RF20000 COBLATION 系统, WEREWOLF COBLATION 系统, WEREWOLF+ COBLATION 系统

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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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