Data / Medical devices / United States / Clear Choice Therapeutics, Inc.
Clear Choice Therapeutics, Inc.: FDA-registered device maker in Raleigh, NC, United States, 3 510(k) clearances
Clear Choice Therapeutics, Inc. is registered with the FDA (registration 3017397434) in Raleigh, NC, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 5, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017397434
- Address
- 1053 E Whitaker Mill Rd Ste 115, Raleigh, NC, United States, 27604
- Owner or operator
- Clear Choice Therapeutics, Inc. (10077792)
- Roles
- Specification developer
- First device listed
- September 23, 2020
- Registered through
- 2026
- Brand names listed
- NPWT Foam Wound Dressing Kit, NPWT PREVENT Kit, PREVENT Barrier Wound Contact Layer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Hydrophilic | NAC | 1 | Specification developer | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | 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 |
|---|---|---|---|---|---|---|
| February 5, 2024 | K232379 | PREVENT Kit | OMP | Substantially Equivalent | Clear Choice Therapeutics | accessdata.fda.gov |
| December 16, 2021 | K211277 | Theia NPWT Foam Wound Dressing Kit | OMP | Substantially Equivalent | Clear Choice Therapeutics, Inc. | accessdata.fda.gov |
| August 29, 2016 | K161570 | Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large | OMP | Substantially Equivalent | Lc Medical Concepts, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
- All makers of Dressing, Wound, Hydrophilic
Updated February 5, 2024. 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.