FDA 510(k)

MENTOR® MemoryGel®增强型一次性凝胶测量器

K号: K241552 · 2024-09-06

决定日期2024-09-06

产品代码MRD

决定实质等同

器械摘要

MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Worldwide, LLC. It received FDA 510(k) clearance on 2024-09-06 under 510(k) number K241552. The device is classified under product code MRD. FDA Decision: Substantially Equivalent.

常见问题

What is the MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer?

MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Mentor Worldwide, LLC. The 510(k) number is K241552.

When did MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer receive FDA 510(k) clearance?

MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer received FDA 510(k) clearance on 2024-09-06, under 510(k) number K241552.

Who is the listed applicant for MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer?

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

What is the FDA product code for MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer?

The FDA product code for MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer is MRD.

列明Mentor Worldwide, LLC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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