Data / Medical devices / United States / Pureway Compliance, Inc.
Pureway Compliance, Inc.: FDA-registered device maker in Katy, TX, United States, 2 510(k) clearances
Pureway Compliance, Inc. is registered with the FDA (registration 3011881552) in Katy, TX, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 14, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011881552
- Address
- 2717 Commercial Center Blvd Ste 200, Katy, TX, United States, 77494
- Owner or operator
- PureWay Compliance, Inc. (10049948)
- Roles
- Specification developer
- First device listed
- September 10, 2015
- Registered through
- 2026
- Brand names listed
- PureWay Sharps Collector Container
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Sharps | MMK | 2 | 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 |
|---|---|---|---|---|---|---|
| September 14, 2023 | K231484 | PureWay 1.4 Quart Sharps Collector | MMK | Substantially Equivalent | Pureway Compliance, Inc. | accessdata.fda.gov |
| September 4, 2015 | K151249 | PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON | MMK | Substantially Equivalent | Pureway Compliance, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 14, 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.