FDA 510(k)

一次性皮下针电极，螺旋形

K号: K241045 · 2024-12-11

决定日期2024-12-11

产品代码GXZ

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决定实质等同

器械摘要

Disposable Subdermal Needle Electrode, Corkscrew is the device name listed in this FDA 510(k) record. The listed applicant is Technomed Europe. It received FDA 510(k) clearance on 2024-12-11 under 510(k) number K241045. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Subdermal Needle Electrode, Corkscrew?

Disposable Subdermal Needle Electrode, Corkscrew is a medical device that received FDA 510(k) clearance on 2024-12-11. The listed applicant is Technomed Europe. The 510(k) number is K241045.

When did Disposable Subdermal Needle Electrode, Corkscrew receive FDA 510(k) clearance?

Disposable Subdermal Needle Electrode, Corkscrew received FDA 510(k) clearance on 2024-12-11, under 510(k) number K241045.

Who is the listed applicant for Disposable Subdermal Needle Electrode, Corkscrew?

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

What is the FDA product code for Disposable Subdermal Needle Electrode, Corkscrew?

The FDA product code for Disposable Subdermal Needle Electrode, Corkscrew is GXZ.

列明Technomed Europe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。

K254183MR 条件杯电极 K253581一次性同心针电极 0.30x25mm 红色 (TE/B50700-001)；一次性同心针电极 0.40x25mm 黄色 (TE/B50700-002)；一次性同心针电极 0.30x30mm 粉色 (TE/B50700-006)；一次性同心针电极 0.45x37mm 绿色 (TE/B50700-003)；一次性同心针电极 0.45x50mm 蓝色 (TE/B50700-004)；一次性同心针电极 0.60x75mm 紫色 (TE/B50700-005)

官方来源

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