FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K180826 |
Allergan |
Natrelle 133 Plus MICROCELL Tissue Expander |
12/21/2018 |
K182054 |
Allergan |
Natrelle 133S Tissue Expander |
08/29/2018 |
K102806 |
ALLERGAN MEDICAL |
NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS |
01/05/2011 |
K143354 |
ALLERGAN, INC. |
Natrelle 133 Plus Tissue Expander |
08/20/2015 |
K983385 |
HUTCHISON INTL., INC. |
HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS |
03/15/1999 |
K112534 |
LIFECELL CORP. |
LIFECELL TISSUE EXPANDER |
08/10/2012 |
K131692 |
MARZ MEDICAL, INC |
BLOSSOM SALINE DELIVERY ASSIST DEVICE |
07/10/2014 |
K011500 |
MENTOR CORP. |
MENTOR CONTOUR PROFILE TISSUE EXPANDER |
12/03/2001 |
K130813 |
MENTOR CORP. |
MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS |
04/11/2013 |
K963066 |
MENTOR CORP. |
MENTOR INJECTION PORT DETECTOR (IPD) |
09/27/1996 |
K150777 |
MENTOR WORLDWIDE LLC |
Artoura Breast Tissue Expander |
04/24/2015 |
K161176 |
MENTOR WORLDWIDE LLC |
ARTOURA Breast Tissue Expanders with Smooth Surface |
05/23/2016 |
K152496 |
MENTOR WORLDWIDE LLC |
CPX 4 Breast Tissue Expander |
02/19/2016 |
K182335 |
Mentor Worldwide LLC |
CPX 4 Breast Tissue Expander with Smooth Surface |
09/25/2018 |
K142998 |
MENTOR WORLDWIDE LLC |
CPX Control Breast Tissue Expander |
12/19/2014 |
K983792 |
SEARE BIOMEDICAL CORP. |
SEARE BIOMEDICAL SILICONE TISSUE EXPANDER |
12/11/1998 |
K214124 |
Sientra, Inc. |
AlloX2 Pro Tissue Expanders |
06/08/2023 |
K221127 |
Sientra, Inc. |
Sientra, inc. Portfinder |
05/10/2023 |
K981852 |
SILIMED, LLC. |
SILIMED TISSUE EXPANDER |
08/05/1998 |
K070303 |
SPECIALTY SURGICAL PRODUCTS |
SILICONE TISSUE EXPANDER |
06/22/2007 |
K140383 |
SPECIALTY SURGICAL PRODUCTS, INC. |
ALLOX2 TISSUE EXPANDERS |
10/28/2014 |
K982067 |
SPECIALTY SURGICAL PRODUCTS, INC. |
MAGNETIC PORT SILICONE TISSUE EXPANDER |
07/13/1998 |
K974209 |
SPECIALTY SURGICAL PRODUCTS, INC. |
SILICONE TISSUE/INFLATABLE TISSUE EXPANDER |
02/06/1998 |
K161483 |
STRADIS HEALTHCARE |
Unger Quad Injector |
10/31/2016 |