Mammary Sizer
FDA product code MRD · Unclassified · General, Plastic Surgery
13510(k) clearances
0PMA approvals
4recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243271 | MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel…MRD · Traditional | Mentor Worldwide, LLC | 01/13/2025SE |
| K241552 | MENTOR MemoryGel Enhance Single Use Gel SizerMRD · Traditional | Mentor Worldwide, LLC | 09/06/2024SE |
| K203229 | NATRELLE INSPIRA Single Use Sizers for Gel ImplantsMRD · Special | Allergan | 06/02/2021SE |
| K200706 | Sientra OPUS Silicone Gel Breast Implant SizerMRD · Traditional | Sientra, Inc. | 11/16/2020SE |
| K183163 | Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMRD · Traditional | Motiva USA, LLC | 02/05/2019SE |
| K151055 | Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILEMRD · Special | Mentor Worldwide, LLC | 05/20/2015SE |
| K131853 | Mentor Memoryshape Resterilizable Gel SizerMRD · Special | Mentor Worldwide, LLC | 07/17/2013SE |
| K062421 | Mentor Resterilizable Gel Breast Implant SizerMRD · Traditional | Mentor Corporation | 10/10/2006SE |
| K010709 | Mentor Sterile Saline Mammary Volume SizersMRD · Traditional | Mentor Corp. | 04/23/2001SE |
| K984106 | Mammary Sizer, Mammary Prothesis SizerMRD · Traditional | Specialty Surgical Products, Inc. | 02/12/1999SE |
| K982258 | Mammary SizerMRD · Traditional | Specialty Surgical Products, Inc. | 09/08/1998SE |
| K961356 | Mammary SizerMRD · Traditional | General Surgical Innovations | 09/23/1996SN |
| K831566 | Cui Mammary Prothesis SizerMRD · Traditional | Cox-Uphuff Intl. | 08/12/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0702-2020 Class III | NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X…The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1… | Allergan PLC | 11/06/2019Terminated |
| Z-1988-2015 Class II | Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The…Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product… | Allergan Inc | 06/08/2015Terminated |
| Z-0964-2015 Class II | MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast…The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those… | Mentor Texas, LP. | 12/11/2014Terminated |
| Z-2591-2014 Class II | EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline…The device labeling is stamped with 330cc and the device is actually 380cc device. | Mentor Texas, LP. | 07/02/2014Terminated |