FDA 510(k)

L12 LED 光源带AIM

K号: K260108 · 2026-02-12

决定日期2026-02-12

产品代码OWN

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决定实质等同

器械摘要

L12 LED Light Source with AIM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2026-02-12 under 510(k) number K260108. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the L12 LED Light Source with AIM?

L12 LED Light Source with AIM is a medical device that received FDA 510(k) clearance on 2026-02-12. The listed applicant is Stryker Endoscopy. The 510(k) number is K260108.

When did L12 LED Light Source with AIM receive FDA 510(k) clearance?

L12 LED Light Source with AIM received FDA 510(k) clearance on 2026-02-12, under 510(k) number K260108.

Who is the listed applicant for L12 LED Light Source with AIM?

FDA 510(k)记录显示Stryker Endoscopy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 L12 LED Light Source with AIM?

The FDA product code for L12 LED Light Source with AIM is OWN.

列明Stryker Endoscopy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。

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