Data / Medical devices / Canada / Xpan Inc.
Xpan Inc.: FDA-registered device maker in Vaughan Ontario, Canada, 1 510(k) clearance
Xpan Inc. is registered with the FDA (registration 3027500817) in Vaughan Ontario, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 2, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027500817
- Address
- 57 Corstate Avenue Suite 200, Vaughan Ontario, Canada, L4K4Y2
- Owner or operator
- Xpan Inc. (10088252)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 26, 2023
- Registered through
- 2026
- Brand names listed
- Xpan Universal Trocar System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Complaint file establishment, 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 2, 2023 | K223562 | Xpan Universal Trocar System | GCJ | Substantially Equivalent | Xpan, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 2, 2023. 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.