FDA 510(k)

Outlook外科Versa One系统（8900139）

K号: K241731 · 2025-08-11

决定日期2025-08-11

产品代码EOB

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决定实质等同

器械摘要

Outlook Surgical Versa One System (8900139) is the device name listed in this FDA 510(k) record. The listed applicant is Resnent, LLC. It received FDA 510(k) clearance on 2025-08-11 under 510(k) number K241731. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Outlook Surgical Versa One System (8900139)?

Outlook Surgical Versa One System (8900139) is a medical device that received FDA 510(k) clearance on 2025-08-11. The listed applicant is Resnent, LLC. The 510(k) number is K241731.

When did Outlook Surgical Versa One System (8900139) receive FDA 510(k) clearance?

Outlook Surgical Versa One System (8900139) received FDA 510(k) clearance on 2025-08-11, under 510(k) number K241731.

Who is the listed applicant for Outlook Surgical Versa One System (8900139)?

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

What is the FDA product code for Outlook Surgical Versa One System (8900139)?

The FDA product code for Outlook Surgical Versa One System (8900139) is EOB.

相关器械（代码：EOB）

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。

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官方来源

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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。

器械摘要

常见问题

相关临床试验

相关器械（代码：EOB）

官方来源