FDA 510(k)

MENTOR® PliaForm®乳房组织扩张器带缝合片

K号: K242963 · 2025-04-24

决定日期2025-04-24

产品代码LCJ

决定实质等同

器械摘要

MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs 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 2025-04-24 under 510(k) number K242963. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

常见问题

What is the MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs?

MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Mentor Worldwide, LLC. The 510(k) number is K242963.

When did MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs receive FDA 510(k) clearance?

MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs received FDA 510(k) clearance on 2025-04-24, under 510(k) number K242963.

Who is the listed applicant for MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs?

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™ PliaForm™ Breast Tissue Expander w/ Suture Tabs?

The FDA product code for MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs 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。

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 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 →

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。