Data / Medical devices / United States / 623 Medical
623 Medical: FDA-registered device maker in Durham, NC, United States, 1 510(k) clearance
623 Medical is registered with the FDA (registration 3018382913) in Durham, NC, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 21, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018382913
- Address
- 4319 S Alston Ave Suite 100, Durham, NC, United States, 27713
- Owner or operator
- 623 Medical (10081199)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 24, 2021
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vapocoolant Device | MLY | U | 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 |
|---|---|---|---|---|---|---|
| December 21, 2020 | K202782 | num Vapocoolant | MLY | Substantially Equivalent | 623 Medical, LLC | accessdata.fda.gov |
Compare with other makers
Updated December 21, 2020. 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.