FDA 510(k)

MENTOR CPX4 PLUS Enhance Breast Tissue Expander

K-Number: K241918 · 2024-08-02

Decision Date2024-08-02

Product CodeLCJ

DecisionSubstantially Equivalent

Device Summary

MENTOR CPX4 PLUS Enhance Breast Tissue Expander is a medical device manufactured by Mentor Worldwide, LLC. It received FDA 510(k) clearance on 2024-08-02 under approval number K241918. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR CPX4 PLUS Enhance Breast Tissue Expander?

MENTOR CPX4 PLUS Enhance Breast Tissue Expander is a medical device that received FDA 510(k) clearance on 2024-08-02. It is manufactured by Mentor Worldwide, LLC. The 510(k) number is K241918.

When was MENTOR CPX4 PLUS Enhance Breast Tissue Expander approved by the FDA?

MENTOR CPX4 PLUS Enhance Breast Tissue Expander received FDA 510(k) clearance on 2024-08-02, under approval number K241918.

What company makes MENTOR CPX4 PLUS Enhance Breast Tissue Expander?

MENTOR CPX4 PLUS Enhance Breast Tissue Expander is manufactured by Mentor Worldwide, LLC.

What is the FDA product code for MENTOR CPX4 PLUS Enhance Breast Tissue Expander?

The FDA product code for MENTOR CPX4 PLUS Enhance Breast Tissue Expander is LCJ.

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 41271017 Lymphedema Imaging and AI: A Review of Diagnostic Modalities, Biomarkers, and Clinical Integration. Biomedical journal (2025)

Other Devices by Mentor Worldwide, LLC

K161176ARTOURA Breast Tissue Expanders with Smooth Surface K152496CPX 4 Breast Tissue Expander K182335CPX 4 Breast Tissue Expander with Smooth Surface K241552MENTOR MemoryGel Enhance Single Use Gel Sizer K242963MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs K243271MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer

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Related Devices (Code: LCJ)

K161483Unger Quad InjectorStradis Healthcare K161176ARTOURA Breast Tissue Expanders with Smooth SurfaceMentor Worldwide, LLC K152496CPX 4 Breast Tissue ExpanderMentor Worldwide, LLC K180826Natrelle 133 Plus MICROCELL Tissue ExpanderAllergan K182335CPX 4 Breast Tissue Expander with Smooth SurfaceMentor Worldwide, LLC K182054Natrelle 133S Tissue ExpanderAllergan

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.