Home / 510(k) Clearances / K062421

510(k) K062421

MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER by Mentor Corporation — Product Code MRD

K062421 is an FDA 510(k) premarket notification submitted by Mentor Corporation for the device "MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER". The FDA issued a decision of Substantially Equivalent on October 10, 2006. The device falls under product code MRD (Mammary Sizer), a Class U device. Mentor Corporation has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2006
Date Received
August 18, 2006
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 Corporation

  • K053296 — MENTOR ARIS SUPRAPUBIC SURGICAL KIT (December 15, 2005)
  • K052440 — MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER (October 11, 2005)
  • K050148 — MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT (March 9, 2005)

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)
  • K151055 — Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE (May 20, 2015)
  • K131853 — MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER (July 17, 2013)
  • 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