Data / Medical devices / United States / Stericycle, Inc.
Stericycle, Inc.: FDA-registered device maker in Bannockburn, IL, United States, 4 510(k) clearances
Stericycle, Inc. is registered with the FDA (registration 3007097064) in Bannockburn, IL, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 27, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007097064
- Address
- 2355 Waukegan Road, Bannockburn, IL, United States, 60015
- Owner or operator
- STERICYCLE, INC. (9012522)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 28, 2008
- Registered through
- 2026
- Brand names listed
- Biobox Funnel Top (Various Sizes), Biobox Traptop (Various Sizes), SURE-WAY REUSABLE SHARPS CONTAINER, Stericycle Sharps Management Service Reusable Sharps Container
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Sharps | MMK | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 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 |
|---|---|---|---|---|---|---|
| December 27, 2013 | K132007 | STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON, RED, STERICYCLE SHARPS MANAGEMENT SERVICES REU | MMK | Substantially Equivalent | Stericycle, Inc. | accessdata.fda.gov |
| December 16, 1999 | K992626 | SURE-WAY REUSABLE SHARPS CONTAINER | FMI | Substantially Equivalent | Sure-Way Systems, Inc. | accessdata.fda.gov |
| August 24, 1995 | K950898 | BIOBOX WITH FUNNEL TOP (SMALL, MEDIUM, LARGE, AND X-LARGE) | MMK | Substantially Equivalent | Biosystems | accessdata.fda.gov |
| August 24, 1995 | K950897 | BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE) | MMK | Substantially Equivalent | Biosystems | accessdata.fda.gov |
Compare with other makers
Updated December 27, 2013. 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.