FDA 510(k)

CPX 4 乳房组织扩张器（表面光滑）

K号: K182335 · 2018-09-25

决定日期2018-09-25

产品代码LCJ

决定实质等同

器械摘要

CPX 4 Breast Tissue Expander with Smooth Surface 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 2018-09-25 under 510(k) number K182335. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

常见问题

What is the CPX 4 Breast Tissue Expander with Smooth Surface?

CPX 4 Breast Tissue Expander with Smooth Surface is a medical device that received FDA 510(k) clearance on 2018-09-25. The listed applicant is Mentor Worldwide, LLC. The 510(k) number is K182335.

When did CPX 4 Breast Tissue Expander with Smooth Surface receive FDA 510(k) clearance?

CPX 4 Breast Tissue Expander with Smooth Surface received FDA 510(k) clearance on 2018-09-25, under 510(k) number K182335.

Who is the listed applicant for CPX 4 Breast Tissue Expander with Smooth Surface?

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 CPX 4 Breast Tissue Expander with Smooth Surface?

The FDA product code for CPX 4 Breast Tissue Expander with Smooth Surface is LCJ.

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 K243271MENTOR® 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 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 K161176ARTOURA 光滑表面乳腺组织扩张器

查看所有 8 个设备 →

官方来源

在 FDA 数据库中查看 →

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。