STERIS Corporation
FDA 510(k) medical device clearances.
Top product codes for STERIS Corporation
Recent clearances by STERIS Corporation
1–100 of 205- K261055 — AMSCO 700 Steam Sterilizer
- K251666 — SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
- K260766 — Celerity 5 HP Biological Indicator (LCB052)
- K252680 — Celerity 20 HP Biological Indicator
- K251048 — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
- K243876 — VERIFY STEAM Integrating Indicator
- K250842 — PADLOCK CLIP EFTR Kit (00713229)
- 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)
- K250061 — Celerity Incubator
- K243475 — Chemical Indicator for enspire CLCSPS (LCC015)
- K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
- K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)
- K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
- K240274 — PADLOCK CLIP EFTR Kit (00713229)
- K240032 — Celerity Chemical Indicator for enspire 3000 CLCSPS
- K240352 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes
- K240098 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
- K233681 — ConFirm 20 Minute Incubator
- K233682 — VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
- 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)
- K232918 — enspire 300 Series Automated Endoscope Reprocessor
- K231746 — VERIFY Spore Test Strip for S40 Sterilant Concentrate
- K223476 — V-PRO maX 2 Low Temperature Sterilization System
- K231490 — Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator
- K231500 — Vis-U-All Low Temperature Sterilization Pouches
- K231501 — PRO-LITE Sterilization Tray
- 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
- K230560 — enspire 300 Series Automated Endoscope Reprocessor System
- K230558 — Revital-Ox PAA High Level Disinfectant Chemical Indicator
- K230930 — enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
- K223715 — Celerity Incubator
- K223717 — Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack
- K230582 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
- 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
- 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
- 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
- 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
- K213881 — Celerity Incubator
- K220395 — EndoGator Endoscopy Irrigation Tubing
- K220361 — Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
- K213262 — CELERITY HP Chemical Indicator
- K211347 — Uretero1 Ureteroscope System
- K212424 — AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers
- 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)
- 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
- K210342 — BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor
- K211500 — AMSCO 600 Medium Steam Sterilizer
- 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
- K202104 — BioGuard EUS Air/Water and Suction Valves
- K202721 — Celerity 20 Steam Biological Indicator for IUSS
- K203199 — RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector
- K202583 — BioShield biopsy valve EUS - Linear
- 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)
- K200446 — STERIS Patient Warming System
- K200126 — VERIFY Assert Self-Contained Biological Indicator
- K200989 — Reliance Endoscope Processing System
- K200577 — RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
- K191715 — Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile
- 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
- K192722 — Padlock Clip defect closure system, Padlock Pro-Select defect closure device
- K191343 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900
- K192020 — Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label
- K190081 — RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
- K190297 — Celerity HP Incubator
- K190917 — V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems
- K183428 — Avulsion Forceps
- 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
- K183410 — AMSCO 600 Steam Sterilizer
- K183401 — Vis-U-All Low Temperature Sterilization Pouch/Tubing
- K183402 — PRO-LITE Sterilization Tray
- K182827 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900
- K183293 — VERIFY VH202 Indicator Tape
- K182568 — V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
- K183294 — CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack
- K183297 — Vis-U-All Low Temperature Sterilization Pouch/Tubing
- K183301 — PRO-LITE Sterilization Tray
- K181865 — Acu-sInQ Complete Endoscope Cleaning Aid System
- K182724 — CelerityTM 10 STEAM Chemical Indicator
- K181686 — CELERITY 20 Steam Biological Indicator
- K181429 — CELERITY 20 HP Biological Indicator
- K181442 — VERIFY Assert Self-Contained Biological Indicator
- K180553 — VERIFY Spore Test Strip for S40 Sterilant
- K180689 — Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device
- K173481 — Amsco Evolution Medium Steam Sterilizer
- K173256 — System 1 endo Liquid Chemical Sterilant Processing System
- K173428 — VERIFY Chemical Indicator for S40 Sterilant
- K173488 — CELERITY 20 HP Challenge Pack
- 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
- K173493 — Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000
- K173485 — Amsco Evolution Medium Steam Sterilizer
- K173490 — Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
- K173626 — Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles
- K173629 — CELERITY 20 Steam Process Challenge Device for Gravity Cycles
- K173634 — CELERITY 20 Steam Biological Indicator
- K173670 — CELERITY 20 Steam Incubator
- K172746 — VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label
- K172749 — Vis-U-All Low Temperature Sterilization Pouch/Tubing
- K172752 — CELERITY 20 HP Biological Indicator
- K172753 — VERIFY VH2O2 Indicator Tape
- K172754 — V-PRO maX 2 Low Temperature Sterilization System
Data sourced from openFDA. This site is unofficial and independent of the FDA.