Product code MRD
- Device name
- Mammary Sizer
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 | 2025-01-13 |
| K241552 | MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer | Mentor Worldwide, LLC | 2024-09-06 |
| K203229 | NATRELLE INSPIRA Single Use Sizers for Gel Implants | Allergan | 2021-06-02 |
| K200706 | Sientra OPUS Silicone Gel Breast Implant Sizer | Sientra, Inc. | 2020-11-16 |
| K183163 | Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix | Motiva USA, LLC | 2019-02-05 |
| K151055 | Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE | Mentor Worldwide, LLC | 2015-05-20 |
| K131853 | MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER | Mentor Worldwide, LLC | 2013-07-17 |
| K062421 | MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER | Mentor Corporation | 2006-10-10 |
| K010709 | MENTOR STERILE SALINE MAMMARY VOLUME SIZERS | Mentor Corp. | 2001-04-23 |
| K984106 | MAMMARY SIZER, MAMMARY PROTHESIS SIZER | Specialty Surgical Products, Inc. | 1999-02-12 |
| K982258 | MAMMARY SIZER | Specialty Surgical Products, Inc. | 1998-09-08 |
| K961356 | MAMMARY SIZER | General Surgical Innovations | 1996-09-23 |
| K831566 | CUI MAMMARY PROTHESIS SIZER | Cox-Uphuff Intl. | 1983-08-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10888628044999 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628045422 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628045415 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628045408 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628045392 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628045385 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628045378 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628045361 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628045354 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628045347 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628045330 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628045323 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628045316 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628044982 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628045002 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628045019 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628045026 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628045033 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-06 |
| 10888628045224 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-05 |
| 10888628045194 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-05 |
| 10888628045200 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-05 |
| 10888628045217 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-05 |
| 10888628045262 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-05 |
| 10888628045231 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-05 |
| 10888628045248 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-05 |
| 10888628045255 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-05 |
| 10888628045309 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-05 |
| 10888628045293 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-05 |
| 10888628045286 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-05 |
| 10888628045279 | NATRELLE INSPIRA Single Use Sizers | Allergan, Inc. | 2022-01-05 |