MRD

FDA Product Code MRD: Mammary Sizer

Leading manufacturers include Mentor Worldwide, LLC, Specialty Surgical Products, Inc. and Mentor Corp..

13
Total
13
Cleared
100d
Avg days
1983
Since
Stable submission activity - 1 submissions in the last 2 years
Consistent review times: 89d avg (recent)

FDA 510(k) Cleared Mammary Sizer Devices (Product Code MRD)

13 devices
1–13 of 13
Cleared Jan 13, 2025
MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer
K243271
Mentor Worldwide, LLC
General & Plastic Surgery · 89d
Cleared Sep 06, 2024
MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer
K241552
Mentor Worldwide, LLC
General & Plastic Surgery · 98d
Cleared Jun 02, 2021
NATRELLE INSPIRA Single Use Sizers for Gel Implants
K203229
Allergan
General & Plastic Surgery · 212d
Cleared Nov 16, 2020
Sientra OPUS Silicone Gel Breast Implant Sizer
K200706
Sientra, Inc.
General & Plastic Surgery · 243d
Cleared Feb 05, 2019
Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix
K183163
Motiva USA, LLC
General & Plastic Surgery · 82d
Cleared May 20, 2015
Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE
K151055
Mentor Worldwide, LLC
General & Plastic Surgery · 30d
Cleared Jul 17, 2013
MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER
K131853
Mentor Worldwide, LLC
General & Plastic Surgery · 26d
Cleared Oct 10, 2006
MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER
K062421
Mentor Corporation
General & Plastic Surgery · 53d
Cleared Apr 23, 2001
MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
K010709
Mentor Corp.
General & Plastic Surgery · 45d
Cleared Feb 12, 1999
MAMMARY SIZER, MAMMARY PROTHESIS SIZER
K984106
Specialty Surgical Products, Inc.
General & Plastic Surgery · 87d
Cleared Sep 08, 1998
MAMMARY SIZER
K982258
Specialty Surgical Products, Inc.
General & Plastic Surgery · 74d
Cleared Sep 23, 1996
MAMMARY SIZER
K961356
General Surgical Innovations
General & Plastic Surgery · 168d

About Product Code MRD - Regulatory Context

510(k) Submission Activity

13 total 510(k) submissions under product code MRD since 1983, with 13 receiving FDA clearance (average review time: 100 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - MRD Product Code

FDA review times for MRD submissions have been consistent, averaging 89 days recently vs 101 days historically.

MRD devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →