FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K071385 |
ADVANCED STERILIZATION PRODUCTS |
STERRAD 100NX STERILIZER |
11/29/2007 |
K092622 |
ADVANCED STERILIZATION PRODUCTS |
STERRAD 100NX STERILIZER EXPRESS CYCLE |
03/04/2011 |
K160903 |
ADVANCED STERILIZATION PRODUCTS |
STERRAD 100NX Sterilizer with ALLClearTM Technology |
09/26/2016 |
K991999 |
ADVANCED STERILIZATION PRODUCTS |
STERRAD 100S STERILIZER |
06/15/2000 |
K030429 |
ADVANCED STERILIZATION PRODUCTS |
STERRAD 200 STERILIZER |
08/18/2003 |
K981625 |
ADVANCED STERILIZATION PRODUCTS |
STERRAD 50 STERILIZER |
01/11/1999 |
K042116 |
ADVANCED STERILIZATION PRODUCTS |
STERRAD NX STERILIZER |
04/22/2005 |
K162007 |
Advanced Sterilization Products |
STERRAD NX Sterilizer |
02/16/2017 |
K142454 |
ADVANCED STERILIZATION PRODUCTS |
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer |
04/03/2015 |
K151725 |
ADVANCED STERILIZATION PRODUCTS |
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer |
01/13/2016 |
K160818 |
ADVANCED STERILIZATION PRODUCTS |
STERRAD« NX Sterilizer with ALLClearÖ Technology |
09/27/2016 |
K111377 |
ADVANCED STERILIZATION PRODUCTS |
STERRAD(R) 100NX STERILIZER DUO CYCLE |
09/13/2012 |
K212174 |
Advanced Sterilization Products, Inc. |
STERRAD 100NX Sterilizer with ALLClear Technology |
10/09/2021 |
K220404 |
Advanced Sterilization Products, Inc. |
STERRAD NX with ALLClear Technology |
05/16/2022 |
K212200 |
Plasmapp Co,.Ltd |
STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette |
10/22/2021 |
K220345 |
Plasmapp Co., Ltd. |
STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terrage |
04/14/2023 |
K231169 |
Plasmapp Co., Ltd. |
STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) |
05/25/2023 |
K223015 |
Plasmapp Co., Ltd. |
STERLINKÖ FPS-15s Plus sterilizer with STERPACKÖ plus cassette |
05/09/2023 |
K140464 |
STERILUCENT, INC |
STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER |
10/31/2014 |
K190005 |
Sterilucent, Inc. |
Sterilucent HC 80TT Hydrogen Peroxide Sterilizer |
09/13/2019 |
K222093 |
STERIS |
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System |
09/09/2022 |
K112813 |
STERIS CORP. |
AMSCO V-PRO |
12/01/2011 |
K111810 |
STERIS Corporation |
AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS |
09/02/2011 |
K083097 |
STERIS Corporation |
AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM |
08/03/2009 |
K162413 |
STERIS Corporation |
AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System |
03/31/2017 |
K172319 |
STERIS Corporation |
AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System |
01/18/2018 |
K102394 |
STERIS Corporation |
AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM |
08/18/2011 |
K131120 |
STERIS Corporation |
AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM |
07/16/2013 |
K120632 |
STERIS Corporation |
AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM |
06/26/2012 |
K102330 |
STERIS Corporation |
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM |
08/12/2011 |
K112760 |
STERIS Corporation |
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM |
11/22/2011 |
K190917 |
STERIS Corporation |
V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems |
05/09/2019 |
K140498 |
STERIS Corporation |
V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM |
07/24/2014 |
K223476 |
Steris Corporation |
V-PRO maX 2 Low Temperature Sterilization System |
08/07/2023 |
K172754 |
Steris Corporation |
V-PRO maX 2 Low Temperature Sterilization System |
02/09/2018 |
K190103 |
STERIS Corporation |
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System |
04/05/2019 |
K182568 |
STERIS Corporation |
V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System |
01/03/2019 |
K160433 |
STERIS CORPORATION |
V-PRO« 1 Plus and V-PRO« maX Low Temperature |
07/06/2016 |
K062297 |
STERIS Corporation |
VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM |
10/04/2007 |