免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Tangent 单次使用数字系统:Tangent 单次使用数字导管和 Tangent 数字控制器

K号: K251170 · 2025-09-12

决定日期2025-09-12
产品代码FBN
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

Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller is the device name listed in this FDA 510(k) record. The listed applicant is Tangent Endoscopy, LLC. It received FDA 510(k) clearance on 2025-09-12 under 510(k) number K251170. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller?

Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Tangent Endoscopy, LLC. The 510(k) number is K251170.

When did Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller receive FDA 510(k) clearance?

Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller received FDA 510(k) clearance on 2025-09-12, under 510(k) number K251170.

Who is the listed applicant for Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller?

The FDA 510(k) record lists Tangent Endoscopy, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller?

The FDA product code for Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller is FBN.

相关临床试验

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。

相关器械(代码:FBN)

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

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。

↑