FDA 510(k)

Anovo 外科系统 (6Ne)

K号: K250591 · 2025-06-06

决定日期2025-06-06

产品代码QNM

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决定实质等同

器械摘要

Anovo Surgical System (6Ne) is the device name listed in this FDA 510(k) record. The listed applicant is Momentis Surgical , Ltd.. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K250591. The device is classified under product code QNM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Anovo Surgical System (6Ne)?

Anovo Surgical System (6Ne) is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Momentis Surgical , Ltd.. The 510(k) number is K250591.

When did Anovo Surgical System (6Ne) receive FDA 510(k) clearance?

Anovo Surgical System (6Ne) received FDA 510(k) clearance on 2025-06-06, under 510(k) number K250591.

Who is the listed applicant for Anovo Surgical System (6Ne)?

FDA 510(k)记录将Momentis Surgical，Ltd.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Anovo Surgical System (6Ne)?

The FDA product code for Anovo Surgical System (6Ne) is QNM.

列明Momentis Surgical , Ltd.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。

K260804Anovo外科手术系统（6Ne）K251761Anovo外科手术系统（型号6Ne）；Anovo仪器ARM曲线剪刀；Anovo仪器ARM钩电极 K251056Anovo 工具 ARM 弯剪；Anovo 工具 ARM 钩电极 K243182Anovo 工具 ARM 弯剪；Anovo 工具 ARM 钩电极 K242157Anovo外科手术系统（型号6Ne）K241907Anovo 外科系统 (型号 6N)

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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。