Medical Device Manufacturer · US , Mentor , OH

Steris

20 submissions · 19 cleared · Since 2021
20
Total
19
Cleared
1
Denied

Steris — FDA 510(k) Submissions

Steris has submitted 20 FDA 510(k) premarket notifications since 2021, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Indicator, Physical/chemical Sterilization Process, Washer, Cleaner, Automated, Endoscope, Electrosurgical, Cutting & Coagulation & Accessories, Indicator, Biological Sterilization Process, Sterilizer, Chemical . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
K251452 · FRC Indicator, Biological... · General Hospital
Jun 2025 28d
Electro Lube NXT
K242773 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 2025 214d
VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator
DEN230085 · SDC Qualitative Cleaning... · General Hospital
Nov 2024 330d
CELERITY HP Indicator Tape (PCC077)
K242189 · JOJ Indicator,... · General Hospital
Aug 2024 26d
MetriCide? OPA Plus Solution Test Strip
K241344 · JOJ Indicator,... · General Hospital
Jun 2024 29d
Electro Lube NXT
K241055 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 2024 44d
CELERITY HP Indicator Tape
K240760 · JOJ Indicator,... · General Hospital
Apr 2024 21d
Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)
K232826 · FBK Endoscopic Injection... · Gastroenterology & Urology
Mar 2024 177d
VERIFY? Chemical Indicator for SYSTEM 1E? and SYSTEM 1? endo Liquid Chemical Sterilant Processing Systems
K233654 · JOJ Indicator,... · General Hospital
Dec 2023 24d
Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)
K233187 · JOJ Indicator,... · General Hospital
Oct 2023 29d
BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)
K232951 · ODC Endoscope Channel Accessory · Gastroenterology & Urology
Oct 2023 29d
V-PRO maX 2 Low Temperature Sterilization System
K233065 · MLR Sterilizer, Chemical · General Hospital
Oct 2023 24d
AMSCO 600 Steam Sterilizer
K232485 · FLE Sterilizer, Steam · General Hospital
Sep 2023 28d
Celerity? HP Chemical Indicator; Celerity? HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape
K231488 · JOJ Indicator,... · General Hospital
Aug 2023 76d
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 Chamber Washer Disinfector
K222849 · NVE Washer, Cleaner,... · General Hospital
Sep 2022 9d
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System
K222093 · MLR Sterilizer, Chemical · General Hospital
Sep 2022 56d
Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays
K222440 · FRG Wrap, Sterilization · General Hospital
Sep 2022 28d
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
K222543 · NVE Washer, Cleaner,... · General Hospital
Aug 2022 3d
CELERITY 20 HP Challenge Pack
K220473 · FRC Indicator, Biological... · General Hospital
Mar 2022 28d
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
K203223 · NZA Accessories, Germicide,... · General Hospital
Jan 2021 87d
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