Data / Medical devices / United States / Contra Healthcare Solutions LLC
Contra Healthcare Solutions LLC: FDA-registered device maker in Butler, PA, United States, 2 510(k) clearances
Contra Healthcare Solutions LLC is registered with the FDA (registration 3023809956) in Butler, PA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023809956
- Address
- 105 Lincoln Ave, Butler, PA, United States, 16001
- Owner or operator
- Contra Healthcare Solutions LLC (10091947)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 1, 2025
- Registered through
- 2026
- Brand names listed
- ContraHealth Bronchoscope, ContraHealth Ureteroscope
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | 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 |
|---|---|---|---|---|---|---|
| April 30, 2025 | K243541 | LumiRex Bronchoscope | EOQ | Substantially Equivalent | Contra Healthcare Solutions, LLC | accessdata.fda.gov |
| April 28, 2025 | K243532 | LumiRex Ureteroscope | FGB | Substantially Equivalent | Contra Healthcare Solutions, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of Ureteroscope And Accessories, Flexible/Rigid
Updated April 30, 2025. 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.