Data / Medical devices / Canada / McNicoll Surgical, Inc.
McNicoll Surgical, Inc.: FDA-registered device maker in Quebec City, Canada, 1 510(k) clearance
McNicoll Surgical, Inc. is registered with the FDA (registration 3031680559) in Quebec City, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 29, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031680559
- Address
- Ave de Vitre, Quebec City, Canada, G1J 1Z6
- Owner or operator
- McNicoll Surgical (10095533)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- March 25, 2026
- Registered through
- 2026
- Brand names listed
- Falco Fusion System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sacroiliac Joint Fixation | OUR | 2 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| January 29, 2026 | K253611 | Falco Fusion System | OUR | Substantially Equivalent | Mcnicoll Surgical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 29, 2026. 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.