FDA 510(k)

CoolSeal 生成器® (CSL-200-90)

K号: K253634 · 2026-06-17

决定日期2026-06-17

产品代码GEI

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决定实质等同

器械摘要

CoolSeal Generator® (CSL-200-90) is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K253634. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CoolSeal Generator® (CSL-200-90)?

CoolSeal Generator® (CSL-200-90) is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Hologic, Inc.. The 510(k) number is K253634.

When did CoolSeal Generator® (CSL-200-90) receive FDA 510(k) clearance?

CoolSeal Generator® (CSL-200-90) received FDA 510(k) clearance on 2026-06-17, under 510(k) number K253634.

Who is the listed applicant for CoolSeal Generator® (CSL-200-90)?

FDA 510(k)记录中列出了Hologic, Inc.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 CoolSeal Generator® (CSL-200-90)?

The FDA product code for CoolSeal Generator® (CSL-200-90) is GEI.

列明Hologic, 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。

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相关器械（代码：GEI）

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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