MRD — Mammary Sizer Class U
FDA Device Classification
Classification Details
- Product Code
- MRD
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K243271 | mentor worldwide | MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel | January 13, 2025 |
| K241552 | mentor worldwide | MENTOR MemoryGel Enhance Single Use Gel Sizer | September 6, 2024 |
| K203229 | allergan | NATRELLE INSPIRA Single Use Sizers for Gel Implants | June 2, 2021 |
| K200706 | sientra | Sientra OPUS Silicone Gel Breast Implant Sizer | November 16, 2020 |
| K183163 | motiva usa | Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix | February 5, 2019 |
| K151055 | mentor worldwide | Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE | May 20, 2015 |
| K131853 | mentor worldwide | MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER | July 17, 2013 |
| K062421 | mentor corporation | MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER | October 10, 2006 |
| K010709 | mentor | MENTOR STERILE SALINE MAMMARY VOLUME SIZERS | April 23, 2001 |
| K984106 | specialty surgical products | MAMMARY SIZER, MAMMARY PROTHESIS SIZER | February 12, 1999 |
| K982258 | specialty surgical products | MAMMARY SIZER | September 8, 1998 |
| K961356 | general surgical innovations | MAMMARY SIZER | September 23, 1996 |
| K831566 | cox-uphuff intl | CUI MAMMARY PROTHESIS SIZER | August 12, 1983 |