Mammary Sizer, Mammary Prothesis Sizer
FDA 510(k) K984106 · Specialty Surgical Products, Inc.
510(k) numberK984106
Submission
- Device name
- Mammary Sizer, Mammary Prothesis Sizer
- Applicant
- Specialty Surgical Products, Inc.
Hamilton, MT, US - Received
- November 17, 1998
- Decision date
- February 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MRD – Mammary Sizer
- Device class
- Unclassified
Other 510(k)s with product code MRD
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|---|---|---|---|
| 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 |
| K982258 | Mammary SizerMRD · Traditional | Specialty Surgical Products, Inc. | 09/08/1998SE |
More from Specialty Surgical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K140383 | ALLOX2 Tissue ExpandersLCJ · Traditional | 10/28/2014SE |
| K070303 | Silicone Tissue ExpanderLCJ · Traditional | 06/22/2007SE |
| K983015 | Virilis Penile ProsthesisFTQ · Traditional | 02/05/1999SE |
| K982258 | Mammary SizerMRD · Traditional | 09/08/1998SE |
| K982065 | Sterile Silicone External Wound CoverMIB · Traditional | 08/12/1998SE |
| K982067 | Magnetic Port Silicone Tissue ExpanderLCJ · Traditional | 07/13/1998SE |
| K974653 | Silicone Elastomer SheetingMIB · Traditional | 03/13/1998SE |
| K974654 | Silicone BlocksMIB · Traditional | 02/24/1998SE |
| K974209 | Silicone Tissue/Inflatable Tissue ExpanderLCJ · Traditional | 02/06/1998SE |
| K973656 | Disposable Silicone Epistaxis CatheterEMX · Traditional | 11/18/1997SE |
Questions and answers
When was Mammary Sizer, Mammary Prothesis Sizer cleared by the FDA?
Mammary Sizer, Mammary Prothesis Sizer (K984106) received a 510(k) decision of Substantially Equivalent on February 12, 1999, 87 days after the submission was received.
What is the product code of K984106?
The FDA product code is MRD – Mammary Sizer, a Unclassified device.