510(k) Report

Devices descending from K011500

14 later devices reach Mentor Contour Profile Tissue Expander through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130813Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue…Mentor Corp.2013134
+2K182335CPX 4 Breast Tissue Expander with Smooth SurfaceMentor Worldwide, LLC20182—
+2K152496CPX 4 Breast Tissue ExpanderMentor Worldwide, LLC20162—
+2K143354Natrelle 133 Plus Tissue ExpanderAllergan, Inc.20153Class I
+2K142998CPX Control Breast Tissue ExpanderMentor Worldwide, LLC20144—
+3K243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC20250—
+3K241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC202413
+3K180826Natrelle 133 Plus MICROCELL Tissue ExpanderAllergan20180—
+3K182054Natrelle 133S Tissue ExpanderAllergan20181—
+3K150777Artoura Breast Tissue ExpanderMentor Worldwide, LLC201532
+4K254126Natrelle 133S Tissue ExpandersAbbVie20260—
+4K161176ARTOURA Breast Tissue Expanders with Smooth SurfaceMentor Worldwide, LLC201622
+5K244026PAL 7020 ConsoleMicroaire Surgical Instruments, LLC20250—
+5K242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsMentor Worldwide, LLC20250—