Data / Medical devices / United States / AbbVie US LLC
AbbVie US LLC: FDA-registered device maker in North Chicago, IL, United States, 3 510(k) clearances
AbbVie US LLC is registered with the FDA (registration 3011299837) in North Chicago, IL, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 14, 2015. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011299837
- FEI number
- 3009751352
- Address
- 1 N Waukegan Rd, North Chicago, IL, United States, 60064
- Owner or operator
- AbbVie Inc. (10046068)
- Roles
- Manufacturer
- First device listed
- January 21, 2015
- Registered through
- 2026
- Brand names listed
- AbbVie Belt Pouch for Vyafuser, AbbVie Chest Pack, AbbVie Combined Fitted Vest, AbbVie Cross Body Pack, AbbVie Fitted Belt, AbbVie Fitted Vest, AbbVie Hip Pack, AbbVie J and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Holder, Syringe | IQG | 1 | Manufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Manufacturer | 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 14, 2015 | K142816 | AbbVie J | KNT | Substantially Equivalent | AbbVie , Inc. | accessdata.fda.gov |
| January 14, 2015 | K142793 | AbbVie PEG | KNT | Unknown | AbbVie , Inc. | accessdata.fda.gov |
| January 14, 2015 | K142792 | AbbVie NJ | KNT | Unknown | AbbVie , Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 27, 2017 | 77129 | Class II | Terminated | AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | accessdata.fda.gov | |
| November 22, 2016 | 75794 | Class II | Terminated | AbbVie PEG Kit 20 FR | AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors. | accessdata.fda.gov |
Compare with other makers
Updated January 14, 2015. 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.