STERIS Corporation

FDA Device Registration & Listing · CLEVELAND, OH, US · Registration 1526531

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1526531
FEI Number
1526531
Entity Name
STERIS Corporation
City/State/Country
CLEVELAND, OH, US
Establishment Address
17820 ENGLEWOOD DR., CLEVELAND, OH 44130, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
STERIS (Owner Number: 10091086)
Owner / Operator Contact Address
5960 Heisley Rd, Mentor, OH 44060, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

V. Mueller Genesis Containers (CL-MF,RR, ST-SD) V. Mueller Neuro/Spine VERSA-TRAC (CL-RR, ST-RR) V. Mueller Retraction and Distraction Platforms (CL-RR, ST-MF,RR) V. Mueller Neuro/Spine Shadow-Line (CL-RR, ST-SD) V. Mueller Instrument Care Emesis Basin (CL-RR, ST-CFE) V. Mueller Genesis Low Temperature Reusable Rigid Container System (CL-RR, MF, ST-SD) Genesis Container Systems (CL-MF,RR, ST-SD) V. Mueller Genesis Reusable Sterilization Container System (CL-MF, ST-SD) DePuy Synthes Sterilization Container System (CL-CM) Genesis Container Systems (CL-RR, ST-SD, CFE) V. Mueller Cassettes and Trays (CL-RR) Genesis Reusable Rigid Sterilization Container System (CL-MF,RR, ST-SD) Genesis containers (CL-MF,RR, ST-SD) V. Mueller Basket Tag (CL-RR, ST-MF) V. Mueller Color Plate (CL-RR, ST-MF) V. Mueller Instrument Care (CL-RR, ST-CFE) Genesis Container Systems (CL-MF,RR, ST-SD) V. Mueller Weisenbach Sterile Forceps (WM-FE,RR) V. Mueller Paparella Sterilizable Case (ST-MF) V. Mueller Instrument Racks (ST-MF) V. Mueller Instrument Holders (ST-MF) V. Mueller (CL-RR, ST-MF, SD, WM-FE,RR)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2024-06-27
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2024-06-27
FNY Basin, Emesis General Hospital Class 1 880.6730 2024-06-27
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2024-06-27
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-06-27
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2024-06-27
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2024-06-27
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-06-27
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2024-06-27
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2024-06-27
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2024-06-27
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2024-06-27
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2024-06-27
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2024-06-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERIS
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3006554912 STERIS Deutschland GmBh Wurmlingen Baden-Wurttemberg, DE
1923569 STERIS Corporation Saint Louis, MO, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243425 Talladium España, SL Guided DAS Surgical Kit 2025-07-22
K213209 K1 Medical, LLC EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device 2021-12-28
K012105 Symmetry Medical, Inc. POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM 2002-08-02
K243317 Infinitum Eta, Ltd. NUVENTUS NV.C™ Surgical Cassette and Tray 2025-02-11
K112536 Covidien SONICISION STERILIZATION TRAY 2012-04-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1526531. Last updated year: 2026. Please use registration number 1526531 when referencing this establishment in official correspondence.
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