FDA 510(k)

Medline 微量切割针（4cm）（140936（ESE104A））；Medline 微量切割针（3cm）（140937（ESE103A））

K号: K242370 · 2024-12-19

决定日期2024-12-19

产品代码GEI

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决定实质等同

器械摘要

Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K242370. 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 Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))?

Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Medline Industries, LP. The 510(k) number is K242370.

When did Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) receive FDA 510(k) clearance?

Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) received FDA 510(k) clearance on 2024-12-19, under 510(k) number K242370.

Who is the listed applicant for Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))?

FDA 510(k)记录显示Medline Industries, LP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 Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))?

The FDA product code for Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) is GEI.

列明Medline Industries, LP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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