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FDA 510(k)

CPX 4 Breast Tissue Expander with Smooth Surface

K-Number: K182335 · 2018-09-25

ApplicantMentor Worldwide, LLC
Decision Date2018-09-25
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

CPX 4 Breast Tissue Expander with Smooth Surface is a medical device manufactured by Mentor Worldwide, LLC. It received FDA 510(k) clearance on 2018-09-25 under approval number K182335. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Mentor Worldwide, LLC. The 510(k) number is K182335.

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

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

What company makes CPX 4 Breast Tissue Expander with Smooth Surface?

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

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026)

Other Devices by Mentor Worldwide, LLC

K161176ARTOURA Breast Tissue Expanders with Smooth Surface K152496CPX 4 Breast Tissue Expander K241552MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer K241918MENTOR™ CPX™4 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 K152496CPX 4 Breast Tissue ExpanderMentor Worldwide, LLC K180826Natrelle 133 Plus MICROCELL Tissue ExpanderAllergan 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.

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