Data / Medical devices / United States / Solo-Dex
Solo-Dex: FDA-registered device maker in Wolf Creek, MT, United States, 1 510(k) clearance
Solo-Dex is registered with the FDA (registration 3010592727) in Wolf Creek, MT, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 22, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010592727
- Address
- 1576 MT Highway 434, Wolf Creek, MT, United States, 59648
- Owner or operator
- Solo-Dex (10052704)
- Roles
- Manufacturer
- First device listed
- September 15, 2016
- Registered through
- 2026
- Brand names listed
- Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | 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 22, 2016 | K151072 | Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit | BSP | Substantially Equivalent | Solo-Dex, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 22, 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.