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510(k) K241918

MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander by Mentor Worldwide, LLC — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2024
Date Received
July 1, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tissue Expander And Accessories
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Mentor Worldwide, LLC

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  • K243836 — Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander (January 12, 2025)
  • K241552 — MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (September 6, 2024)
  • K182335 — CPX 4 Breast Tissue Expander with Smooth Surface (September 25, 2018)
  • K161176 — ARTOURA Breast Tissue Expanders with Smooth Surface (May 23, 2016)
  • K152496 — CPX 4 Breast Tissue Expander (February 19, 2016)
  • K151055 — Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE (May 20, 2015)
  • K150777 — Artoura Breast Tissue Expander (April 24, 2015)
  • K142998 — CPX Control Breast Tissue Expander (December 19, 2014)

Other clearances for product code LCJ

  • K254126 — Natrelle 133S Tissue Expanders (January 16, 2026)
  • K242963 — MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs (April 24, 2025)
  • K243836 — Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander (January 12, 2025)
  • K211676 — Motiva Flora SmoothSilk Tissue Expander (October 13, 2023)
  • K214124 — AlloX2 Pro Tissue Expanders (June 8, 2023)
  • K221127 — Sientra, inc. Portfinder (May 10, 2023)
  • K180826 — Natrelle 133 Plus MICROCELL Tissue Expander (December 21, 2018)
  • K182335 — CPX 4 Breast Tissue Expander with Smooth Surface (September 25, 2018)
  • K182054 — Natrelle 133S Tissue Expander (August 29, 2018)
  • K161483 — Unger Quad Injector (October 31, 2016)