510(k) Report

Devices descending from K130813

13 later devices reach Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast… through their predicates, nearest generation first.

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