MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer
FDA 510(k) K243271 · Mentor Worldwide, LLC
510(k) numberK243271
Submission
- Device name
- MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer
- Applicant
- Mentor Worldwide, LLC
Irvine, CA, US - Received
- October 16, 2024
- Decision date
- January 13, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRD – Mammary Sizer
- Device class
- Unclassified
Other 510(k)s with product code MRD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Specialty Surgical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242963 | MENTOR PliaForm Breast Tissue Expander w/ Suture TabsLCJ · Traditional | 04/24/2025SE |
| K243836 | Mentor CPX 4 PLUS Enhance Breast Tissue ExpanderLCJ · Special | 01/12/2025SE |
| K241552 | MENTOR MemoryGel Enhance Single Use Gel SizerMRD · Traditional | 09/06/2024SE |
| K241918 | MENTOR CPX4 PLUS Enhance Breast Tissue ExpanderLCJ · Special | 08/02/2024SE |
| K182335 | CPX 4 Breast Tissue Expander with Smooth SurfaceLCJ · Special | 09/25/2018SE |
| K161176 | ARTOURA Breast Tissue Expanders with Smooth SurfaceLCJ · Special | 05/23/2016SE |
| K152496 | CPX 4 Breast Tissue ExpanderLCJ · Traditional | 02/19/2016SE |
| K151055 | Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILEMRD · Special | 05/20/2015SE |
| K150777 | Artoura Breast Tissue ExpanderLCJ · Special | 04/24/2015SE |
| K142998 | CPX Control Breast Tissue ExpanderLCJ · Traditional | 12/19/2014SE |
Questions and answers
When was MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer cleared by the FDA?
MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer (K243271) received a 510(k) decision of Substantially Equivalent on January 13, 2025, 89 days after the submission was received.
What is the product code of K243271?
The FDA product code is MRD – Mammary Sizer, a Unclassified device.