Data / Medical devices / United States / Excelent
Excelent: FDA-registered device maker in Durham, NC, United States, 1 510(k) clearance
Excelent is registered with the FDA (registration 3027553379) in Durham, NC, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 25, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027553379
- Address
- 68 TW Alexander Drive, PO BOX 13628 Research Triangle Park, Durham, NC, United States, 27709
- Owner or operator
- EXCELENT (10088310)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 27, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Ent Manual Surgical | LRC | 1 | Complaint file establishment, 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 25, 2023 | K230258 | BB 8 Sinus Dilation Kit | LRC | Substantially Equivalent | Excelent, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 25, 2023. 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.