FDA 510(k)

KARL STORZ 双极切除镜带高频电缆

K号: K221893 · 2023-03-17

决定日期2023-03-17

产品代码FJL

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决定实质等同

器械摘要

KARL STORZ Bipolar Resectoscopes with HF Cable is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2023-03-17 under 510(k) number K221893. The device is classified under product code FJL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KARL STORZ Bipolar Resectoscopes with HF Cable?

KARL STORZ Bipolar Resectoscopes with HF Cable is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K221893.

When did KARL STORZ Bipolar Resectoscopes with HF Cable receive FDA 510(k) clearance?

KARL STORZ Bipolar Resectoscopes with HF Cable received FDA 510(k) clearance on 2023-03-17, under 510(k) number K221893.

Who is the listed applicant for KARL STORZ Bipolar Resectoscopes with HF Cable?

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

What is the FDA product code for KARL STORZ Bipolar Resectoscopes with HF Cable?

The FDA product code for KARL STORZ Bipolar Resectoscopes with HF Cable is FJL.

列明Karl Storz Endoscopy America, 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。

K252624KARL STORZ 喉镜和附件 K240506KARL STORZ 托架 K223885HOPKINS 望远镜 K230359KOH 超微注射针 (26167NN)；吸引和冲洗针，L. 36cm (37360CP)；吸引和冲洗针，L. 36cm (37360SC)；吸引和冲洗针，L. 36cm (37560LH)；吸引和冲洗针，L. 30cm (37260LH)；KOH 超微注射针 (26167NA)；穿刺针，LUER-lock (26178R)；吸引和冲洗针，L. 43cm (37460LH)；吸引和冲洗针，L. 36cm (37360LH)；穿刺针，直径 1.6 mm，36 cm (26175R)；双向旋塞 (26167H)；注射针，LUER-K223520UNIDRIVE SIII 系统 K223923HOPKINS 望远镜

查看所有 46 个设备 →

相关器械（代码：FJL）

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。

K232486KARL STORZ单极电切镜带高频电缆Karl Storz SE & CO. KG K230205Veloxion系统Corinth Medtech, Inc.K191341Veloxion控制器套件，Veloxion流体控制系统，Veloxion切除镜，Veloxion视频控制系统，Veloxion滚筒支架，废物管理管路，组织收集器，废物管理袋Corinth Medtech, Inc.K190099Veloxion控制器套件，Veloxion流体控制套件，Veloxion切除镜，Veloxion视频控制单元，Veloxion滚筒架，废物管理管路，组织收集器Corinth Medtech, Inc.K162979Veloxion系统Corinth Medtech, Inc.

官方来源

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