FDA.report

510(k) K243836

Device
Mentor? CPX ? 4 PLUS Enhance Breast Tissue Expander
Applicant
Mentor Worldwide, LLC
510(k) number
K243836
Product code
LCJ
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-12
Date received
2024-12-13
Classification name
Tissue Expander And Accessories
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Catherine Carvalho
Address
31 Technology Dr. Irvine CA US 92618 92618

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code LCJ

510(k)DeviceApplicantDecision date
K254126Natrelle 133S Tissue ExpandersAbbVie2026-01-16
K242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsMentor Worldwide, LLC2025-04-24
K241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC2024-08-02
K211676Motiva Flora SmoothSilk Tissue ExpanderMotiva USA, LLC2023-10-13
K214124AlloX2 Pro Tissue ExpandersSientra, Inc.2023-06-08
K221127Sientra, inc. PortfinderSientra, Inc.2023-05-10
K180826Natrelle 133 Plus MICROCELL Tissue ExpanderAllergan2018-12-21
K182335CPX 4 Breast Tissue Expander with Smooth SurfaceMentor Worldwide, LLC2018-09-25
K182054Natrelle 133S Tissue ExpanderAllergan2018-08-29
K161483Unger Quad InjectorStradis Healthcare2016-10-31
K161176ARTOURA Breast Tissue Expanders with Smooth SurfaceMentor Worldwide, LLC2016-05-23
K152496CPX 4 Breast Tissue ExpanderMentor Worldwide, LLC2016-02-19
K143354Natrelle 133 Plus Tissue ExpanderAllergan, Inc.2015-08-20
K150777Artoura Breast Tissue ExpanderMentor Worldwide, LLC2015-04-24
K142998CPX Control Breast Tissue ExpanderMentor Worldwide, LLC2014-12-19