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STERIS Corporation FDA Approvals
0 new drug approvals and 50 device clearances on file. Matched by name to STE.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| AMSCO 700 Steam Sterilizer510(k)Jun 24, 2026General Hospital |
| Celerity 5 HP Biological Indicator (LCB052)510(k)Apr 8, 2026General Hospital |
| SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900510(k)Apr 8, 2026General Hospital |
| Celerity 20 HP Biological Indicator510(k)Sep 24, 2025General Hospital |
| Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118510(k)May 2, 2025General Hospital |
| VERIFY STEAM Integrating Indicator510(k)Apr 25, 2025General Hospital |
| PADLOCK CLIP EFTR Kit (00713229)510(k)Apr 18, 2025Gastroenterology, Urology |
| Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)510(k)Feb 6, 2025General Hospital |
| Celerity Incubator510(k)Feb 6, 2025General Hospital |
| Chemical Indicator for enspire CLCSPS (LCC015)510(k)Dec 4, 2024General Hospital |
| enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System510(k)Dec 2, 2024Gastroenterology, Urology |
| Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)510(k)Nov 8, 2024Gastroenterology, Urology |
| DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)510(k)Oct 11, 2024Gastroenterology, Urology |
| PADLOCK CLIP EFTR Kit (00713229)510(k)Sep 17, 2024Gastroenterology, Urology |
| Celerity Chemical Indicator for enspire 3000 CLCSPS510(k)Apr 17, 2024General Hospital |
| Defendo Single Use Cleaning Adapter for Olympus Endoscopes510(k)Mar 6, 2024Gastroenterology, Urology |
| DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)510(k)Feb 9, 2024Gastroenterology, Urology |
| ConFirm 20 Minute Incubator510(k)Dec 15, 2023General Hospital |
| VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE510(k)Dec 15, 2023General Hospital |
| 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)510(k)Oct 3, 2023General Hospital |
| enspire 300 Series Automated Endoscope Reprocessor510(k)Oct 3, 2023Gastroenterology, Urology |
| VERIFY Spore Test Strip for S40 Sterilant Concentrate510(k)Sep 11, 2023General Hospital |
| PRO-LITE Sterilization Tray510(k)Aug 7, 2023General Hospital |
| V-PRO maX 2 Low Temperature Sterilization System510(k)Aug 7, 2023General Hospital |
| Vis-U-All Low Temperature Sterilization Pouches510(k)Aug 7, 2023General Hospital |
| Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator510(k)Aug 7, 2023General Hospital |
| 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 VIS101510(k)Jul 25, 2023Gastroenterology, Urology |
| enspire 300 Series Automated Endoscope Reprocessor System510(k)Jul 21, 2023Gastroenterology, Urology |
| Revital-Ox PAA High Level Disinfectant Chemical Indicator510(k)Jul 17, 2023General Hospital |
| enspire 3000 Cleaning and Liquid Chemical Sterile Processing System510(k)Jun 30, 2023Gastroenterology, Urology |
| Celerity Incubator510(k)Jun 15, 2023General Hospital |
| Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack510(k)Jun 15, 2023General Hospital |
| SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900510(k)Mar 28, 2023General Hospital |
| 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 VIS101510(k)Feb 17, 2023Gastroenterology, Urology |
| 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 2000184510(k)Dec 2, 2022General, Plastic Surgery |
| 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 Concentrate510(k)Sep 28, 2022General Hospital |
| 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 2000184510(k)Aug 18, 2022General, Plastic Surgery |
| Celerity Incubator510(k)Jul 21, 2022General Hospital |
| EndoGator Endoscopy Irrigation Tubing510(k)Mar 11, 2022Gastroenterology, Urology |
| Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide510(k)Mar 10, 2022Gastroenterology, Urology |
| CELERITY HP Chemical Indicator510(k)Jan 7, 2022General Hospital |
| Uretero1 Ureteroscope System510(k)Nov 23, 2021Gastroenterology, Urology |
| AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers510(k)Oct 28, 2021General Hospital |
| 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)510(k)Oct 7, 2021Gastroenterology, Urology |
| 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 Concentrate510(k)Sep 7, 2021General Hospital |
| BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor510(k)Sep 3, 2021Gastroenterology, Urology |
| AMSCO 600 Medium Steam Sterilizer510(k)Aug 25, 2021General Hospital |
| 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 Concentrate510(k)May 12, 2021General Hospital |
| BioGuard EUS Air/Water and Suction Valves510(k)Jan 14, 2021Gastroenterology, Urology |
| Celerity 20 Steam Biological Indicator for IUSS510(k)Jan 8, 2021General Hospital |