Atlas FDA

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

FDA 510(k) clearance K243271 · decided 2025-01-13

Clearance details

K-number
K243271
Device name
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
Decision
Substantially Equivalent
Date received
2024-10-16
Decision date
2025-01-13
Days to decision
89 days
Clearance type
Traditional
Product code
MRD
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
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 MEMORYSHAPE RESTERILIZABLE GEL SIZER (K131853)Mentor Worldwide, LLC2013-07-17
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/S058)Mentor Worldwide, LLC2026-07-21
MENTOR Saline-Filled and Spectrum™ Breast Implants (P990075/S068)Mentor Worldwide, LLC2026-05-12
MENTOR™ MemoryShape™ Breast Implants (P060028/S060)Mentor Worldwide, LLC2026-02-04
MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants (P990075/S067)Mentor Worldwide, LLC2026-02-04
MENTOR™ MemoryShape™ Breast Implants (P060028/S059)Mentor Worldwide, LLC2026-01-02
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