510(k) K183163

Device: Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix
Applicant: Motiva USA, LLC
510(k) number: K183163
Product code: MRD
Decision: Substantially Equivalent (SESE)
Decision date: 2019-02-05
Date received: 2018-11-15
Classification name: Sizer, Mammary, Breast Implant Volume
Medical specialty: Unknown
Review panel: General & Plastic Surgery
Device class: U
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
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
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

summary