510(k) K062421
- Device
- MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER
- Applicant
- MENTOR CORPORATION
- 510(k) number
- K062421
- Product code
- MRD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-10-10
- Date received
- 2006-08-18
- Regulation
- 510(k) Premarket Notification
- Classification name
- Sizer, Mammary, Breast Implant Volume
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NICOLA SELLEY
- Address
- 201 Mentor Dr. Santa Barbara CA US 93111 93111
FDA Registration Numbers#
- 3011310987
- 3014279513
- 2011068
- 1649518
- 3016050935
- 3031984
- 1645337
- 1720929
- 3005423519
- 3012883202
- 9617229
Source Documents#
Other 510(k) Records For Product Code MRD #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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