MRD · Mammary Sizer
· Class U
Overview
| Product Code | MRD |
|---|---|
| Device Name | Mammary Sizer |
| Device Class | Class U |
| Review Panel |
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243271 | MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer | Mentor Worldwide, LLC | Jan 13, 2025 | SESE |
| K241552 | MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer | Mentor Worldwide, LLC | Sep 6, 2024 | SESE |
| K203229 | NATRELLE INSPIRA Single Use Sizers for Gel Implants | Allergan | Jun 2, 2021 | SESE |
| K200706 | Sientra OPUS Silicone Gel Breast Implant Sizer | Sientra, Inc. | Nov 16, 2020 | SESE |
| K183163 | Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix | Motiva USA, LLC | Feb 5, 2019 | SESE |
| K151055 | Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE | Mentor Worldwide, LLC | May 20, 2015 | SESE |
| K131853 | MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER | Mentor Worldwide, LLC | Jul 17, 2013 | SESE |
| K062421 | MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER | Mentor Corporation | Oct 10, 2006 | SESE |
| K010709 | MENTOR STERILE SALINE MAMMARY VOLUME SIZERS | Mentor Corp. | Apr 23, 2001 | SESE |
| K984106 | MAMMARY SIZER, MAMMARY PROTHESIS SIZER | Specialty Surgical Products, Inc. | Feb 12, 1999 | SESE |
| K982258 | MAMMARY SIZER | Specialty Surgical Products, Inc. | Sep 8, 1998 | SESE |
| K961356 | MAMMARY SIZER | General Surgical Innovations | Sep 23, 1996 | SN |
| K831566 | CUI MAMMARY PROTHESIS SIZER | Cox-Uphuff Intl. | Aug 12, 1983 | SESE |
Top Applicants
- Mentor Worldwide, LLC — 4 clearances
- Specialty Surgical Products, Inc. — 2 clearances
- Allergan — 1 clearance
- Cox-Uphuff Intl. — 1 clearance
- General Surgical Innovations — 1 clearance
