510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243271Substantially Equivalent

MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer

Mentor Worldwide, LLC, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243271 is the FDA 510(k) clearance record for MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer, cleared for Mentor Worldwide, LLC on under FDA product code MRD (Mammary Sizer). FDA records list 12 510(k) clearances for Mentor Worldwide, LLC, from to . As of , FDA records show no recalls naming K243271.

Clearance record

Decision date
Received
(89 days to decision)
Product code
MRD Mammary Sizer
Device class
Unclassified
Review panel
Unknown
Applicant
Mentor Worldwide, LLC 31 Technology Dr., Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MRD

Trailing 12 months

FDA records hold no clearances under product code MRD in the trailing twelve months.

FDA records show no clearances under product code MRD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MRD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260