FDA 510(k)

CPX 4 Breast Tissue Expander

K-Number: K152496 · 2016-02-19

Decision Date2016-02-19

Product CodeLCJ

DecisionSubstantially Equivalent

Device Summary

CPX 4 Breast Tissue Expander is a medical device manufactured by Mentor Worldwide, LLC. It received FDA 510(k) clearance on 2016-02-19 under approval number K152496. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPX 4 Breast Tissue Expander?

CPX 4 Breast Tissue Expander is a medical device that received FDA 510(k) clearance on 2016-02-19. It is manufactured by Mentor Worldwide, LLC. The 510(k) number is K152496.

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

CPX 4 Breast Tissue Expander received FDA 510(k) clearance on 2016-02-19, under approval number K152496.

What company makes CPX 4 Breast Tissue Expander?

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

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

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

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Other Devices by Mentor Worldwide, LLC

K161176ARTOURA Breast Tissue Expanders with Smooth Surface 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 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 K180826Natrelle 133 Plus MICROCELL Tissue ExpanderAllergan K182335CPX 4 Breast Tissue Expander with Smooth SurfaceMentor Worldwide, LLC K182054Natrelle 133S Tissue ExpanderAllergan K211676Motiva Flora SmoothSilk Tissue ExpanderMotiva USA, LLC

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.