FDA 510(k)

Mentor CPX 4 PLUS Enhance Breast Tissue Expander

K-Number: K243836 · 2025-01-12

Decision Date2025-01-12

Product CodeLCJ

DecisionSubstantially Equivalent

Device Summary

Mentor CPX 4 PLUS Enhance Breast Tissue Expander is a medical device manufactured by Mentor Worldwide, LLC. It received FDA 510(k) clearance on 2025-01-12 under approval number K243836. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mentor CPX 4 PLUS Enhance Breast Tissue Expander?

Mentor CPX 4 PLUS Enhance Breast Tissue Expander is a medical device that received FDA 510(k) clearance on 2025-01-12. It is manufactured by Mentor Worldwide, LLC. The 510(k) number is K243836.

When was Mentor CPX 4 PLUS Enhance Breast Tissue Expander approved by the FDA?

Mentor CPX 4 PLUS Enhance Breast Tissue Expander received FDA 510(k) clearance on 2025-01-12, under approval number K243836.

What company makes Mentor CPX 4 PLUS Enhance Breast Tissue Expander?

Mentor CPX 4 PLUS Enhance Breast Tissue Expander is manufactured by Mentor Worldwide, LLC.

What is the FDA product code for Mentor CPX 4 PLUS Enhance Breast Tissue Expander?

The FDA product code for Mentor CPX 4 PLUS Enhance Breast Tissue Expander is LCJ.

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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 K241918MENTOR CPX4 PLUS Enhance Breast Tissue Expander K242963MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs

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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.