FDA 510(k) Applications Submitted by Anthony Piotrkowski

FDA 510(k) Number Submission Date Device Name Applicant
K170070 01/09/2017 VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles STERIS Corporation
K200126 01/21/2020 VERIFY Assert Self-Contained Biological Indicator STERIS Corporation
K190103 01/22/2019 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 STERIS Corporation
K190297 02/11/2019 Celerity HP Incubator Steris Corporation
K220473 02/18/2022 CELERITY 20 HP Challenge Pack STERIS
K160485 02/22/2016 VERIFY VH2O2 Indicator Tape STERIS CORPORATION
K240760 03/20/2024 CELERITY HP Indicator Tape STERIS
K160908 04/01/2016 Vis-U-All Low Temperature Sterilization Pouch/Tubing STERIS CORPORATION
K160912 04/01/2016 Sterilization Tray STERIS CORPORATION
K230930 04/03/2023 enspire 3000 Cleaning and Liquid Chemical Sterile Processing System STERIS Corporation
K190917 04/09/2019 V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems STERIS Corporation
K241344 05/13/2024 MetriCideÖ OPA Plus Solution Test Strip Steris
K211500 05/14/2021 AMSCO 600 Medium Steam Sterilizer Steris Corporation
K171504 05/23/2017 VERIFY Assert VH2O2 Self-Contained Biological Indicator STERIS Corporation
K231488 05/23/2023 CelerityÖ HP Chemical Indicator; CelerityÖ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape STERIS
K171587 05/31/2017 VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator Steris Corporation
K181442 06/01/2018 VERIFY Assert Self-Contained Biological Indicator STERIS Corporation
K181429 06/01/2018 CELERITY 20 HP Biological Indicator STERIS Corporation
K222093 07/15/2022 V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System STERIS
K242189 07/25/2024 CELERITY HP Indicator Tape (PCC077) Steris
K212424 08/04/2021 AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers STERIS Corporation
K222440 08/12/2022 Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays Steris
K172474 08/15/2017 Celerity 20 HP Biological Indicator Steris Corporation
K232485 08/16/2023 AMSCO 600 Steam Sterilizer Steris
K222543 08/22/2022 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector Steris
K202721 09/17/2020 Celerity 20 Steam Biological Indicator for IUSS STERIS Corporation
K222849 09/21/2022 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Ch Steris
K162701 09/28/2016 VERIFY Assert Self-Contained Biological Indicator STERIS CORPORATION
K233187 09/28/2023 Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) Steris
K162758 09/30/2016 VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack STERIS Corporation
K213262 09/30/2021 CELERITY HP Chemical Indicator Steris Corporation
K203061 10/08/2020 Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco STERIS Corporation
K173493 11/13/2017 Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 STERIS Corporation
K173490 11/13/2017 Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) STERIS Corporation
K173488 11/13/2017 CELERITY 20 HP Challenge Pack STERIS Corporation
K173481 11/13/2017 Amsco Evolution Medium Steam Sterilizer STERIS Corporation
K173485 11/13/2017 Amsco Evolution Medium Steam Sterilizer STERIS Corporation
K233654 11/14/2023 VERIFY« Chemical Indicator for SYSTEM 1E« and SYSTEM 1« endo Liquid Chemical Sterilant Processing Systems STERIS
K223476 11/18/2022 V-PRO maX 2 Low Temperature Sterilization System Steris Corporation
K143333 11/20/2014 Revital-Ox RESERT Solution Test Strip STERIS Corporation
K173634 11/24/2017 CELERITY 20 Steam Biological Indicator STERIS Corporation
K173629 11/24/2017 CELERITY 20 Steam Process Challenge Device for Gravity Cycles STERIS Corporation
K173626 11/24/2017 Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles STERIS Corporation
K183293 11/27/2018 VERIFY VH202 Indicator Tape STERIS Corporation
K183294 11/27/2018 CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack STERIS Corporation
K173670 11/30/2017 CELERITY 20 Steam Incubator STERIS Corporation
K183410 12/10/2018 AMSCO 600 Steam Sterilizer STERIS Corporation
DEN230085 12/18/2023 VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator STERIS
K163587 12/20/2016 VERIFY Incubator for Assert Self Contained Biological Indicators STERIS Corporation


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