Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008776287

FEI Number

3008776287

Entity Name

STERIS Corporation

City/State/Country

Richmond, CA, US

Establishment Address

503 Canal Blvd, ad, Richmond, CA 94804, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

STERIS Corporation (Owner Number: 10078069)

Owner / Operator Contact Address

5960 Heisley Road, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133413

PMA Number

N/A

All Registered Proprietary Names

Vision1 Imaging Console and Display System (VIS101) (RM-MF) Uretero 1 Reverse Deflection (URORD101) (RM-SD) Uretero 1 Standard Deflection (UROSD101) (RM-SD) Uretero 1 Reverse Deflection (URORD101) (RM-SD) Uretero 1 Standard Deflection (UROSD101) (RM-SD) Vision1 Imaging Console and Display System (VIS101) (RM-MF) VividImage 32" 4K Surgical display (RM-RR) VividImage 27" 4K Surgical Monitor (RM-CFE) G-Series HD Camera in Case (MG-MF) VividImage 31" 4K Surgical Monitor (RM-CFE) 58" Display Monitor (8MP) (RM-RR) 55" Vividimage W HD Wall Display (RM-RR) HexaVue IP In-Light Camera Control System (RM-MF) M-Series HD Camera (MG-MF) VividImage W 4K 65 4K Medical Wall Display (RM-RR) Vividimage W HD Wall Display (42") (RM-RR) Free 5 Camera System (RM-CFE) Harmony iQ 2800-SLC (RM-CFE) Vividimage D HD Surgical Display (27") (RM-RR) Harmony iQ 2400-SLC (RM-CFE) Harmony iQ 3600-SLC (RM-CFE) IDSS-SLC (version 7 and 8) (RM-CFE) Vividimage T HD Surgical Display (RM-CFE) Vividimage W HD Wall Display 50-inch (RM-CFE) HexaVue Focus In-Light Camera Control System (RM-MF) Vividimage W HD Wall Display 65-inch (RM-RR) A-Series HD Camera (MG-MF) HexaVue Focus Integration System-Surgical Light Control (RM-MF) Hexalux Sterilizable Light Handle (MG-MF) Harmony iQ 3600-SLC (RM-CFE) Sterile Handle Camera Cover (MG-SD, RO-RR) Sterile Light Handle Cover (MG-SD, RO-RR) IDSS-SLC (version 7 and 8) (RM-CFE) Universal Light Handle Cover (MG-SD, RO-RR) Harmony iQ 2400-SLC (RM-CFE) Harmony iQ 2800-SLC (RM-CFE) HexaVue IP In-Light Control Systems (RM-MF) Vision1 Imaging Console and Display System (VIS101) (RM-MF) Uretero 1 Standard Deflection (UROSD101) (RM-SD) Uretero 1 Reverse Deflection (URORD101) (RM-SD) IDSS-SLC Version 6 (RM-CFE)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-02-23
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-08-03
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2020-10-09
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2020-10-10
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-11-30
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2020-10-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERIS Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018811167	MEDIVATORS INC	Rogers, MN, US
3038285067	Synergy Sterilisation Kulim (M) Sdn. Bhd	Seberang Perai Selatan Pulau Pinang, MY
3031571464	Herotron E-Beam Service GmbH	Bitterfeld Saxony-Anhalt, DE
3010897183	Synergy Health Marseille SAS	CHUSCLAN Gard, FR
3008252486	ELECTRON BEAM SDN BHD	Port Klang Selangor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008776287. Last updated year: 2026. Please use registration number 3008776287 when referencing this establishment in official correspondence.