FDA.reportPublic FDA data

510(k) K242963

Device
MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs
Applicant
Mentor Worldwide, LLC
510(k) number
K242963
Product code
LCJ
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-24
Date received
2024-09-25
Classification name
Tissue Expander And Accessories
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Alicia Botham
Address
31 Technology Dr. Irvine CA US 92614 92614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LCJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254126Natrelle 133S Tissue ExpandersAbbVie2026-01-16
K243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC2025-01-12
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