Data / Medical devices / United States / STERIS Corporation
STERIS Corporation: FDA-registered device maker in Cleveland, OH, United States, 10 510(k) clearances
STERIS Corporation is registered with the FDA (registration 1526531) in Cleveland, OH, United States. It lists 7 device types. The FDA files 10 510(k) clearances under its listings, the newest dated March 21, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1526531
- Address
- 17820 Englewood DR., Cleveland, OH, United States, 44130
- Owner or operator
- STERIS (10091086)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- June 27, 2024
- Registered through
- 2027
- Brand names listed
- DePuy Synthes Sterilization Container System (CL-CM), Genesis Container Systems (CL-MF,RR, ST-SD), Genesis Container Systems (CL-RR, ST-SD, CFE), Genesis Reusable Rigid Sterilization Container System (CL-MF,RR, ST-SD), Genesis containers (CL-MF,RR, ST-SD), Sterilization Process Indicator (CL-RR, ST-CFE), Synthes Reusable Sterilization Container System (CL-CM), V. Mueller (CL-RR, ST-MF, SD, WM-FE,RR) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Basin, Emesis | FNY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Self-Retaining, For Neurosurgery | GZT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 21, 2016 | K153554 | Genesis Low Temperature Reusable Rigid Container System | KCT | Substantially Equivalent | Carefusion 2200, Inc. | accessdata.fda.gov |
| January 8, 2015 | K142529 | Genesis Reusable Rigid Container System | KCT | Substantially Equivalent | Carefusion 2200, Inc. | accessdata.fda.gov |
| August 27, 2014 | K140850 | GENESIS REUSABLE RIGID CONTAINER SYSTEM | KCT | Substantially Equivalent | Carefusion 2200, Inc. | accessdata.fda.gov |
| April 27, 2012 | K112535 | GENESIS REUSABLE RIGID CONTAINER SYSTEM | KCT | Substantially Equivalent | Carefusion 2200, Inc. | accessdata.fda.gov |
| April 15, 2011 | K110152 | SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS | JOJ | Substantially Equivalent | Spsmedical Supply Corp. | accessdata.fda.gov |
| August 20, 2002 | K012931 | GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM | FRG | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| August 4, 2000 | K983299 | ALLEGIANCE GENESIS CONTAINER SYSTEM | FRG | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| March 7, 1997 | K962545 | DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE | KCT | Substantially Equivalent | Sterilization Cassette Systems, Inc. | accessdata.fda.gov |
| January 23, 1997 | K964402 | VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM | GZT | Substantially Equivalent | V. Mueller Neuro/Spine | accessdata.fda.gov |
| December 12, 1984 | K844652 | C.A.S.E. CONTAINER | FSM | Substantially Equivalent | General Medical Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Tray, Surgical, Instrument
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Basin, Emesis
- All makers of Wrap, Sterilization
- All makers of Retractor, Self-Retaining, For Neurosurgery
Updated March 21, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.