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STERIS Corporation

FDA 510(k) & PMA Approved Devices — 119 products

Total Devices119
Categories23
Latest Approval2026-04-08
TypeNumberDevice NameCodeDate
510(k) K251666 SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 MED 2026-04-08 View
510(k) K260766 Celerity 5 HP Biological Indicator (LCB052) FRC 2026-04-08 View
510(k) K252680 Celerity™ 20 HP Biological Indicator FRC 2025-09-24 View
510(k) K251048 Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 JOJ 2025-05-02 View
510(k) K243876 VERIFY STEAM Integrating Indicator JOJ 2025-04-25 View
510(k) K250842 PADLOCK CLIP EFTR Kit (00713229) PKL 2025-04-18 View
510(k) K250044 Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) FRC 2025-02-06 View
510(k) K250061 Celerity Incubator FRC 2025-02-06 View
510(k) K243475 Chemical Indicator for enspire CLCSPS (LCC015) JOJ 2024-12-04 View
510(k) K243433 enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System FEB 2024-12-02 View
510(k) K243075 Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) ODC 2024-11-08 View
510(k) K242742 DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) ODC 2024-10-11 View
510(k) K240274 PADLOCK CLIP EFTR Kit (00713229) PKL 2024-09-17 View
510(k) K240032 Celerity Chemical Indicator for enspire 3000 CLCSPS JOJ 2024-04-17 View
510(k) K240352 Defendo Single Use Cleaning Adapter for Olympus Endoscopes ODC 2024-03-06 View
510(k) K240098 DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) ODC 2024-02-09 View
510(k) K233682 VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE OVY 2023-12-15 View
510(k) K233681 ConFirm 20 Minute Incubator FRC 2023-12-15 View
510(k) K232914 SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) MED 2023-10-03 View
510(k) K232918 enspire 300 Series Automated Endoscope Reprocessor NZA 2023-10-03 View
510(k) K231746 VERIFY Spore Test Strip for S40 Sterilant Concentrate OVY 2023-09-11 View
510(k) K231490 Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator FRC 2023-08-07 View
510(k) K231500 Vis-U-All Low Temperature Sterilization Pouches FRG 2023-08-07 View
510(k) K223476 V-PRO maX 2 Low Temperature Sterilization System MLR 2023-08-07 View
510(k) K231501 PRO-LITE Sterilization Tray KCT 2023-08-07 View
510(k) K231878 Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101 FGB 2023-07-25 View
510(k) K230560 enspire 300 Series Automated Endoscope Reprocessor System NZA 2023-07-21 View
510(k) K230558 Revital-Ox PAA High Level Disinfectant Chemical Indicator JOJ 2023-07-17 View
510(k) K230930 enspire 3000 Cleaning and Liquid Chemical Sterile Processing System FEB 2023-06-30 View
510(k) K223715 Celerity Incubator FRC 2023-06-15 View
510(k) K223717 Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack FRC 2023-06-15 View
510(k) K230582 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 MED 2023-03-28 View
510(k) K223466 Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 FGB 2023-02-17 View
510(k) K223369 truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 GEH 2022-12-02 View
510(k) K222615 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate MED 2022-09-28 View
510(k) K222272 truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 GEH 2022-08-18 View
510(k) K213881 Celerity Incubator FRC 2022-07-21 View
510(k) K220395 EndoGator Endoscopy Irrigation Tubing FEQ 2022-03-11 View
510(k) K220361 Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide NZA 2022-03-10 View
510(k) K213262 CELERITY HP Chemical Indicator QKM 2022-01-07 View
510(k) K211347 Uretero1 Ureteroscope System FGB 2021-11-23 View
510(k) K212424 AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers FLE 2021-10-28 View
510(k) K212860 SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) FDI 2021-10-07 View
510(k) K211607 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate MED 2021-09-07 View
510(k) K210342 BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor ODC 2021-09-03 View
510(k) K211500 AMSCO 600 Medium Steam Sterilizer FLE 2021-08-25 View
510(k) K210737 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate MED 2021-05-12 View
510(k) K202104 BioGuard EUS Air/Water and Suction Valves ODC 2021-01-14 View
510(k) K202721 Celerity 20 Steam Biological Indicator for IUSS FRC 2021-01-08 View
510(k) K203199 RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector NVE 2020-12-01 View
510(k) K202583 BioShield biopsy valve EUS - Linear ODD 2020-11-06 View
510(k) K203061 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 EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS) FLE 2020-11-06 View
510(k) K200446 STERIS Patient Warming System DWJ 2020-06-13 View
510(k) K200126 VERIFY Assert Self-Contained Biological Indicator FRC 2020-05-22 View
510(k) K200989 Reliance Endoscope Processing System NZA 2020-05-14 View
510(k) K200577 RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector NVE 2020-04-03 View
510(k) K191715 Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile OCU 2020-01-27 View
510(k) K192929 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 MED 2019-12-10 View
510(k) K192722 Padlock Clip defect closure system, Padlock Pro-Select defect closure device PKL 2019-10-24 View
510(k) K192020 Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label JOJ 2019-09-05 View
510(k) K191343 SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 MED 2019-09-05 View
510(k) K190081 RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector NVE 2019-08-21 View
510(k) K190297 Celerity HP Incubator FRC 2019-05-14 View
510(k) K190917 V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems MLR 2019-05-09 View
510(k) K183428 Avulsion Forceps KGE 2019-04-16 View
510(k) K190103 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 MLR 2019-04-05 View
510(k) K183410 AMSCO 600 Steam Sterilizer FLE 2019-03-27 View
510(k) K183401 Vis-U-All Low Temperature Sterilization Pouch/Tubing FRG 2019-03-01 View
510(k) K183402 PRO-LITE Sterilization Tray KCT 2019-03-01 View
510(k) K182827 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 MED 2019-01-31 View
510(k) K183293 VERIFY VH202 Indicator Tape JOJ 2019-01-04 View
510(k) K183294 CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack FRC 2019-01-03 View
510(k) K183301 PRO-LITE Sterilization Tray KCT 2019-01-03 View
510(k) K182568 V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System MLR 2019-01-03 View
510(k) K183297 Vis-U-All Low Temperature Sterilization Pouch/Tubing FRG 2019-01-03 View
510(k) K181865 Acu-sInQ Complete Endoscope Cleaning Aid System FEB 2018-12-14 View
510(k) K182724 CelerityTM 10 STEAM Chemical Indicator JOJ 2018-12-10 View
510(k) K181686 CELERITY 20 Steam Biological Indicator FRC 2018-07-24 View
510(k) K181442 VERIFY Assert Self-Contained Biological Indicator OWP 2018-06-13 View
510(k) K181429 CELERITY 20 HP Biological Indicator FRC 2018-06-13 View
510(k) K180553 VERIFY Spore Test Strip for S40 Sterilant OVY 2018-05-29 View
510(k) K180689 Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device PKL 2018-04-12 View
510(k) K173481 Amsco Evolution Medium Steam Sterilizer FLE 2018-03-09 View
510(k) K173428 VERIFY Chemical Indicator for S40 Sterilant JOJ 2018-03-02 View
510(k) K173256 System 1 endo Liquid Chemical Sterilant Processing System MED 2018-03-02 View
510(k) K173488 CELERITY 20 HP Challenge Pack FRC 2018-03-01 View
510(k) K173633 VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag FRC 2018-02-28 View
510(k) K173493 Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 FLE 2018-02-23 View
510(k) K173485 Amsco Evolution Medium Steam Sterilizer FLE 2018-02-22 View
510(k) K173490 Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) FLE 2018-02-22 View
510(k) K173629 CELERITY 20 Steam Process Challenge Device for Gravity Cycles FRC 2018-02-21 View
510(k) K173626 Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles FRC 2018-02-21 View
510(k) K173670 CELERITY 20 Steam Incubator FRC 2018-02-12 View
510(k) K173634 CELERITY 20 Steam Biological Indicator FRC 2018-02-12 View
510(k) K172746 VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label JOJ 2018-02-09 View
510(k) K172754 V-PRO maX 2 Low Temperature Sterilization System MLR 2018-02-09 View
510(k) K172749 Vis-U-All Low Temperature Sterilization Pouch/Tubing FRG 2018-02-09 View
510(k) K172753 VERIFY VH2O2 Indicator Tape JOJ 2018-02-09 View
510(k) K172752 CELERITY 20 HP Biological Indicator FRC 2018-02-09 View
510(k) K172755 PRO-LITE Sterilization Trays KCT 2018-02-09 View
510(k) K172319 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 MLR 2018-01-18 View
510(k) K172474 Celerity 20 HP Biological Indicator FRC 2017-12-29 View
510(k) K172472 Micro-MEC 1.8% Glutaraldehyde Monitor Strip JOJ 2017-11-17 View
510(k) K170956 SYSTEM 1E Liquid Chemical Sterilant Processing System MED 2017-09-22 View
510(k) K171504 VERIFY Assert VH2O2 Self-Contained Biological Indicator FRC 2017-08-22 View
510(k) K171587 VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator FRC 2017-08-22 View
510(k) K170070 VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles FRC 2017-04-28 View
510(k) K162945 VERIFY ASSERT STEAM Process Challenge Device OWP 2017-04-28 View
510(k) K162413 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 MLR 2017-03-31 View
510(k) K162701 VERIFY Assert Self-Contained Biological Indicator OWP 2017-03-24 View
510(k) K163587 VERIFY Incubator for Assert Self Contained Biological Indicators OWP 2017-03-24 View
510(k) K162758 VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack JOJ 2017-03-21 View
510(k) K162631 VERIFY STEAM Integrating Indicator - Short JOJ 2017-01-27 View
510(k) K160912 Sterilization Tray KCT 2016-10-07 View
510(k) K161683 SYSTEM 1E Liquid Chemical Sterilant Processing System MED 2016-08-05 View
510(k) K160908 Vis-U-All Low Temperature Sterilization Pouch/Tubing FRG 2016-07-22 View
510(k) K160433 V-PRO® 1 Plus and V-PRO® maX Low Temperature MLR 2016-07-06 View
510(k) K160485 VERIFY VH2O2 Indicator Tape JOJ 2016-06-01 View
510(k) K152630 VERIFY STEAM Integrating Indicator JOJ 2016-05-12 View
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