Data / Medical devices / United States / CeQur Corporation
CeQur Corporation: FDA-registered device maker in Greenville, SC, United States, 1 510(k) clearance
CeQur Corporation is registered with the FDA (registration 3007871880) in Greenville, SC, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 7, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007871880
- Address
- 355 S Main St 1st and 2nd Floor, Greenville, SC, United States, 29601
- Owner or operator
- CeQur Corporation (10046968)
- Roles
- Complaint file establishment
- First device listed
- February 4, 2019
- Registered through
- 2026
- Brand names listed
- CeQur Simplicity Patch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Infusion, Insulin | LZG | 2 | Complaint file establishment | accessdata.fda.gov |
| Pump, Infusion, Insulin Bolus | OPP | 2 | Complaint file establishment | 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 7, 2017 | K163357 | OneTouch Via On-Demand Insulin Delivery System | OPP | Substantially Equivalent | Lifescan Europe, A Division of Cilag GmbH | accessdata.fda.gov |
Compare with other makers
Updated June 7, 2017. 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.