FDA 510(k)

Anspach螺旋解剖工具

K号: K183545 · 2019-07-19

决定日期2019-07-19

产品代码HBE

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决定实质等同

器械摘要

Anspach Helix Dissection Tools is the device name listed in this FDA 510(k) record. The listed applicant is The Anspach Effort, Inc.. It received FDA 510(k) clearance on 2019-07-19 under 510(k) number K183545. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Anspach Helix Dissection Tools?

Anspach Helix Dissection Tools is a medical device that received FDA 510(k) clearance on 2019-07-19. The listed applicant is The Anspach Effort, Inc.. The 510(k) number is K183545.

When did Anspach Helix Dissection Tools receive FDA 510(k) clearance?

Anspach Helix Dissection Tools received FDA 510(k) clearance on 2019-07-19, under 510(k) number K183545.

Who is the listed applicant for Anspach Helix Dissection Tools?

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

What is the FDA product code for Anspach Helix Dissection Tools?

The FDA product code for Anspach Helix Dissection Tools is HBE.

列明The Anspach Effort, 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。

K220485无线手控装置，EG1A（WIRELESS-HC），无线手控装置接收器，EG1A（RECEIVER-HC）K180063OCM-G1 连接件

相关器械（代码：HBE）

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。

官方来源

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