FDA 510(k)

Plasma Edge切除和汽化电极，Plasma Edge工作元件，适配器Plasma Edge

K号: K213135 · 2022-03-02

决定日期2022-03-02

产品代码FAS

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge is the device name listed in this FDA 510(k) record. The listed applicant is Chirurgie Innovation. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K213135. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge?

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Chirurgie Innovation. The 510(k) number is K213135.

When did Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge receive FDA 510(k) clearance?

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge received FDA 510(k) clearance on 2022-03-02, under 510(k) number K213135.

Who is the listed applicant for Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge?

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

What is the FDA product code for Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge?

The FDA product code for Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge is FAS.

列明Chirurgie Innovation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。

K163090Plasma Edge系统

相关器械（代码：FAS）

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。

K251403Dornier 双极电极 BIP12CLM 双极 12° 中度切割环 24 Fr 电极-无菌，一次性使用 BIP12CLL 双极 12° 大度切割环 24 Fr 电极-无菌，一次性使用 BIP30CLM 双极 30° 中度切割环 24 Fr 电极-无菌，一次性使用 BIP30CLL 双极 30° 大度切割环 24 Fr 电极-无菌，一次性使用 BIPMBLA 双极中度膀胱环 24 Fr 电极-无菌，一次性使用 BIPNEEL 双极针 24 Fr 电极-无菌，一次性使用 BIPDDSC 双极盘 )Dornier Medtech America Inc (Dmta)K250522Multi4系统Multi4 Medical AB K240504PLASMA EDGE 系统Lamidey Noury Medical K210651带 HF 电缆的 Resection 电极Olympus Winter & Ibe GmbH K210394电外科附件Dornier Medtech America, Inc.K171965带 HF 电缆的 Resection 电极Olympus Winter & Ibe GmbH

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。