Data / Medical devices / Canada / George Courey Inc
George Courey Inc: FDA-registered device maker in Montreal Quebec, Canada, 2 510(k) clearances
George Courey Inc is registered with the FDA (registration 3015068387) in Montreal Quebec, Canada. It lists 9 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 6, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015068387
- Address
- 6220 Ernest Cormier, Montreal Quebec, Canada, H7C 2T5
- Owner or operator
- George Courey Inc (10087297)
- Roles
- Complaint file establishment, Exporter to the US, Specification developer
- First device listed
- February 9, 2023
- Registered through
- 2026
- Brand names listed
- George Courey
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cover, Mattress (Medical Purposes) | FMW | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Device, Transfer, Patient, Manual | FMR | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Dress, Surgical | FYE | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Complaint file establishment, Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 6, 2025 | K250321 | GCI Sterilization Wrappers | FRG | Substantially Equivalent | George Courey, Inc. | accessdata.fda.gov |
| August 2, 2024 | K233571 | GCI Surgical Gown | FYA | Substantially Equivalent | George Courey, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Transfer, Patient, Manual
- All makers of Non-Surgical Gown
- All makers of Fiber, Medical, Absorbent
- All makers of Gown, Surgical
- All makers of Drape, Surgical, Exempt
- All makers of Dress, Surgical
Updated June 6, 2025. 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.