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510(k) K243271

MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer by Mentor Worldwide, LLC — Product Code MRD

K243271 is an FDA 510(k) premarket notification submitted by Mentor Worldwide, LLC for the device "MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer". The FDA issued a decision of Substantially Equivalent on January 13, 2025. The device falls under product code MRD (Mammary Sizer), a Class U device. Mentor Worldwide, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2025
Date Received
October 16, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mammary Sizer
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Mentor Worldwide, LLC

  • K242963 — MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs (April 24, 2025)
  • K243836 — Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander (January 12, 2025)
  • K241552 — MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (September 6, 2024)
  • K241918 — MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander (August 2, 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 MRD

  • K241552 — MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (September 6, 2024)
  • K203229 — NATRELLE INSPIRA Single Use Sizers for Gel Implants (June 2, 2021)
  • K200706 — Sientra OPUS Silicone Gel Breast Implant Sizer (November 16, 2020)
  • K183163 — Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix (February 5, 2019)
  • K151055 — Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE (May 20, 2015)
  • K131853 — MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER (July 17, 2013)
  • K062421 — MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER (October 10, 2006)
  • K010709 — MENTOR STERILE SALINE MAMMARY VOLUME SIZERS (April 23, 2001)
  • K984106 — MAMMARY SIZER, MAMMARY PROTHESIS SIZER (February 12, 1999)
  • K982258 — MAMMARY SIZER (September 8, 1998)

FDA data resources