Data / Medical devices / United States / Genteel, LLC
Genteel, LLC: FDA-registered device maker in West Linn, OR, United States, 1 510(k) clearance
Genteel, LLC is registered with the FDA (registration 3012677227) in West Linn, OR, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 12, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012677227
- Address
- 2904 Rawhide St, West Linn, OR, United States, 97068
- Owner or operator
- Genteel, LLC (10095620)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- April 3, 2026
- Registered through
- 2026
- Brand names listed
- GENTEEL BUTTERFLY TOUCH LANCETS, GENTEEL LANCING DEVICE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| May 12, 2016 | K153670 | Genteel Lancing Device | FMK | Substantially Equivalent | Genteel, LLC | accessdata.fda.gov |
Compare with other makers
Updated May 12, 2016. 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.