Medical Device Manufacturer · US , Mentor , OH

STERIS Corporation - FDA 510(k) Cleared Devices

202 submissions · 200 cleared · Since 1997
202
Total
200
Cleared
2
Denied

FDA 510(k) cleared devices by STERIS Corporation Gastroenterology & Urology

18 devices
1-18 of 18
Cleared Apr 18, 2025
PADLOCK CLIP EFTR Kit (00713229)
K250842 · PKL
Gastroenterology & Urology · 29d
Cleared Nov 08, 2024
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323,...
K243075 · ODC
Gastroenterology & Urology · 42d
Cleared Oct 11, 2024
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
K242742 · ODC
Gastroenterology & Urology · 30d
Cleared Sep 17, 2024
PADLOCK CLIP EFTR Kit (00713229)
K240274 · PKL
Gastroenterology & Urology · 230d
Cleared Mar 06, 2024
Defendo Single Use Cleaning Adapter for Olympus Endoscopes
K240352 · ODC
Gastroenterology & Urology · 30d
Cleared Feb 09, 2024
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
K240098 · ODC
Gastroenterology & Urology · 28d
Cleared Jul 25, 2023
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN...
K231878 · FGB
Gastroenterology & Urology · 29d
Cleared Feb 17, 2023
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN...
K223466 · FGB
Gastroenterology & Urology · 92d
Cleared Mar 11, 2022
EndoGator Endoscopy Irrigation Tubing
K220395 · FEQ
Gastroenterology & Urology · 28d
Cleared Nov 23, 2021
Uretero1 Ureteroscope System
K211347 · FGB
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...
K212860 · FDI
Gastroenterology & Urology · 29d
Cleared Sep 03, 2021
BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing,...
K210342 · ODC
Gastroenterology & Urology · 210d
Cleared Jan 14, 2021
BioGuard EUS Air/Water and Suction Valves
K202104 · ODC
Gastroenterology & Urology · 169d
Cleared Nov 06, 2020
BioShield biopsy valve EUS - Linear
K202583 · ODD
Gastroenterology & Urology · 59d
Cleared Jan 27, 2020
Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile
K191715 · OCU
Gastroenterology & Urology · 215d
Cleared Oct 24, 2019
Padlock Clip defect closure system, Padlock Pro-Select defect closure device
K192722 · PKL
Gastroenterology & Urology · 27d
Cleared Apr 16, 2019
Avulsion Forceps
K183428 · KGE
Gastroenterology & Urology · 126d
Cleared Apr 12, 2018
Padlock Clip defect closure device
K180689 · PKL
Gastroenterology & Urology · 28d
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