FDA 510(k) Applications for Medical Device Product Code: MRD (Sizer, Mammary, Breast Implant Volume)

FDA 510(k) Applications for Medical Device Product Code "MRD"
(Sizer, Mammary, Breast Implant Volume)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K203229	Allergan	NATRELLE INSPIRA Single Use Sizers for Gel Implants	06/02/2021
K961356	GENERAL SURGICAL INNOVATIONS	MAMMARY SIZER	09/23/1996
K010709	MENTOR CORP.	MENTOR STERILE SALINE MAMMARY VOLUME SIZERS	04/23/2001
K062421	MENTOR CORPORATION	MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER	10/10/2006
K151055	MENTOR WORLDWIDE LLC	Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE	05/20/2015
K131853	MENTOR WORLDWIDE LLC	MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER	07/17/2013
K183163	Motiva USA, LLC	Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix	02/05/2019
K200706	Sientra, Inc	Sientra OPUS Silicone Gel Breast Implant Sizer	11/16/2020
K982258	SPECIALTY SURGICAL PRODUCTS, INC.	MAMMARY SIZER	09/08/1998
K984106	SPECIALTY SURGICAL PRODUCTS, INC.	MAMMARY SIZER, MAMMARY PROTHESIS SIZER	02/12/1999