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FDA 510(k)

MENTOR® MemoryShape®可复灭菌凝胶乳房植入物测量器；MENTOR® MemoryGel®可复灭菌凝胶乳房植入物测量器；MENTOR® MemoryGel®增强型一次性凝胶测量器

K号: K243271 · 2025-01-13

申请人Mentor Worldwide, LLC
决定日期2025-01-13
产品代码MRD
决定实质等同

器械摘要

MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; 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 2025-01-13 under 510(k) number K243271. The device is classified under product code MRD. FDA Decision: Substantially Equivalent.

常见问题

What is the MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer?

MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Mentor Worldwide, LLC. The 510(k) number is K243271.

When did MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer receive FDA 510(k) clearance?

MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer received FDA 510(k) clearance on 2025-01-13, under 510(k) number K243271.

Who is the listed applicant for MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; 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™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer?

The FDA product code for MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer is MRD.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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。

K242963MENTOR® PliaForm®乳房组织扩张器带缝合片K243836Mentor™ CPX™ 4 PLUS增强乳房组织扩张器K241552MENTOR® MemoryGel®增强型一次性凝胶测量器K241918MENTOR® CPX®4 PLUS增强型乳房组织扩张器K182335CPX 4 乳房组织扩张器（表面光滑）K161176ARTOURA 光滑表面乳腺组织扩张器

查看所有 8 个设备 →

相关器械（代码：MRD）

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。

K241552MENTOR® MemoryGel®增强型一次性凝胶测量器Mentor Worldwide, LLCK203229NATRELLE INSPIRA 一次性凝胶植入物测量器AllerganK200706Sientra OPUS 硅胶乳房假体测量器Sientra, Inc.K183163一次性、无菌、硅胶乳房测量器Motiva植入矩阵Motiva USA, LLC

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。

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