STERIS Corporation - FDA 510(k) Cleared Devices
Recent clearances: SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700, Celerity 5 HP Biological Indicator (LCB052), Celerity™ 20 HP Biological Indicator
204
Total
202
Cleared
2
Denied
FDA 510(k) Regulatory Record - STERIS Corporation Gastroenterology & Urology ✕
18 devices
Cleared
Apr 18, 2025
PADLOCK CLIP EFTR Kit (00713229)
Gastroenterology & Urology
29d
Cleared
Nov 08, 2024
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323,...
Gastroenterology & Urology
42d
Cleared
Oct 11, 2024
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
Gastroenterology & Urology
30d
Cleared
Sep 17, 2024
PADLOCK CLIP EFTR Kit (00713229)
Gastroenterology & Urology
230d
Cleared
Mar 06, 2024
Defendo Single Use Cleaning Adapter for Olympus Endoscopes
Gastroenterology & Urology
30d
Cleared
Feb 09, 2024
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
Gastroenterology & Urology
28d
Cleared
Jul 25, 2023
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN...
Gastroenterology & Urology
29d
Cleared
Feb 17, 2023
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN...
Gastroenterology & Urology
92d
Cleared
Mar 11, 2022
EndoGator Endoscopy Irrigation Tubing
Gastroenterology & Urology
28d
Cleared
Nov 23, 2021
Uretero1 Ureteroscope System
Gastroenterology & Urology
204d
Cleared
Oct 07, 2021
SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack...
Gastroenterology & Urology
29d
Cleared
Sep 03, 2021
BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing,...
Gastroenterology & Urology
210d