FDA.report

510(k) K243271

Device
MENTOR? MemoryShape? Resterilizable Gel Breast Implant Sizer; MENTOR? MemoryGel? Resterilizable Gel Breast Implant Sizer; MENTOR? MemoryGel? Enhance Single Use Gel Sizer
Applicant
Mentor Worldwide, LLC
510(k) number
K243271
Product code
MRD
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-13
Date received
2024-10-16
Classification name
Mammary Sizer
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Saakshi Arora-Tice
Address
31 Technology Dr. Irvine CA US 92614 92614

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MRD

510(k)DeviceApplicantDecision date
K241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLC2024-09-06
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K200706Sientra OPUS Silicone Gel Breast Implant SizerSientra, Inc.2020-11-16
K183163Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMotiva USA, LLC2019-02-05
K151055Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILEMentor Worldwide, LLC2015-05-20
K131853MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZERMentor Worldwide, LLC2013-07-17
K062421MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZERMentor Corporation2006-10-10
K010709MENTOR STERILE SALINE MAMMARY VOLUME SIZERSMentor Corp.2001-04-23
K984106MAMMARY SIZER, MAMMARY PROTHESIS SIZERSpecialty Surgical Products, Inc.1999-02-12
K982258MAMMARY SIZERSpecialty Surgical Products, Inc.1998-09-08
K961356MAMMARY SIZERGeneral Surgical Innovations1996-09-23
K831566CUI MAMMARY PROTHESIS SIZERCox-Uphuff Intl.1983-08-12