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510(k) K151055

Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE by Mentor Worldwide, LLC — Product Code MRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2015
Date Received
April 20, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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Other clearances for product code MRD

  • K243271 — MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ (January 13, 2025)
  • 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)
  • 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)