Product Code: MRD FDA unclassified

Mammary Sizer

Unknown

The Mammary Sizer is a general surgery device used during breast augmentation surgery to help the surgeon select the appropriate size implant by temporarily placing a sizer of known volume in the pocket to assess the aesthetic outcome before choosing the final implant. This device is currently unclassified by the FDA, reviewed by the General and Plastic Surgery panel. The product code is MRD.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code MRD in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: MRD
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 13 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243271	MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer	Jan 13, 2025	Substantially Equivalent	Mentor Worldwide, LLC
K241552	MENTOR MemoryGel Enhance Single Use Gel Sizer	Sep 06, 2024	Substantially Equivalent	Mentor Worldwide, LLC
K203229	NATRELLE INSPIRA Single Use Sizers for Gel Implants	Jun 02, 2021	Substantially Equivalent	Allergan
K200706	Sientra OPUS Silicone Gel Breast Implant Sizer	Nov 16, 2020	Substantially Equivalent	Sientra, Inc.
K183163	Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix	Feb 05, 2019	Substantially Equivalent	Motiva USA, LLC
K151055	Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE	May 20, 2015	Substantially Equivalent	Mentor Worldwide, LLC
K131853	MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER	Jul 17, 2013	Substantially Equivalent	Mentor Worldwide, LLC
K062421	MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER	Oct 10, 2006	Substantially Equivalent	Mentor Corporation
K010709	MENTOR STERILE SALINE MAMMARY VOLUME SIZERS	Apr 23, 2001	Substantially Equivalent	Mentor Corp.
K984106	MAMMARY SIZER, MAMMARY PROTHESIS SIZER	Feb 12, 1999	Substantially Equivalent	Specialty Surgical Products, Inc.
K982258	MAMMARY SIZER	Sep 08, 1998	Substantially Equivalent	Specialty Surgical Products, Inc.
K961356	MAMMARY SIZER	Sep 23, 1996	Substantially Equivalent for Some Indications	General Surgical Innovations
K831566	CUI MAMMARY PROTHESIS SIZER	Aug 12, 1983	Substantially Equivalent	Cox-Uphuff Intl.