Atlas FDA

MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER

FDA 510(k) clearance K131853 · decided 2013-07-17

Clearance details

K-number
K131853
Device name
MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER
Applicant
Mentor Worldwide, LLC
Decision
Substantially Equivalent
Date received
2013-06-21
Decision date
2013-07-17
Days to decision
26 days
Clearance type
Special
Product code
MRD
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Santa Barbara, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Mentor Worldwide

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (K243271)Mentor Worldwide, LLC2025-01-13
MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (K241552)Mentor Worldwide, LLC2024-09-06
NATRELLE INSPIRA Single Use Sizers for Gel Implants (K203229)Allergan2021-06-02
Sientra OPUS Silicone Gel Breast Implant Sizer (K200706)Sientra, Inc.2020-11-16
Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix (K183163)Motiva USA, LLC2019-02-05
Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE (K151055)Mentor Worldwide, LLC2015-05-20
MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER (K062421)Mentor Corporation2006-10-10
MENTOR STERILE SALINE MAMMARY VOLUME SIZERS (K010709)Mentor Corp.2001-04-23
MAMMARY SIZER, MAMMARY PROTHESIS SIZER (K984106)Specialty Surgical Products, Inc.1999-02-12
MAMMARY SIZER (K982258)Specialty Surgical Products, Inc.1998-09-08
MAMMARY SIZER (K961356)General Surgical Innovations1996-09-23
CUI MAMMARY PROTHESIS SIZER (K831566)Cox-Uphuff Intl.1983-08-12

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
MENTOR™ MemoryShape™ Breast Implants (P060028/S057)Mentor Worldwide, LLC2025-12-17
MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants (P990075/S066)Mentor Worldwide, LLC2025-12-17
MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants (P990075/S065)Mentor Worldwide, LLC2025-11-18
Saline and SPECTRUM™ Saline-Filled Breast Implants (P990075/S063)Mentor Worldwide, LLC2025-08-12
MemoryShape™ Silicone Gel-Filled Breast Implants (P060028/S055)Mentor Worldwide, LLC2025-08-12
MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants (P990075/S064)Mentor Worldwide, LLC2025-08-08
MENTOR™ MemoryShape™ Breast Implants (P060028/S056)Mentor Worldwide, LLC2025-08-08
MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES (P990075/S062)Mentor Worldwide, LLC2025-05-21