Data / Medical devices / United States / Cool Renewal, LLC
Cool Renewal, LLC: FDA-registered device maker in Nashville, TN, United States, 1 510(k) clearance
Cool Renewal, LLC is registered with the FDA (registration 3012697079) in Nashville, TN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 6, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012697079
- FEI number
- 3012327827
- Address
- 2515 Eugenia Ave Ste 103, Nashville, TN, United States, 37211
- Owner or operator
- Cool Renewal, LLC (10052288)
- Roles
- Manufacturer
- First device listed
- July 11, 2016
- Registered through
- 2026
- Brand names listed
- Cool Renewal
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Unit, Cryosurgical, Accessories | GEH | 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 |
|---|---|---|---|---|---|---|
| July 6, 2016 | K161296 | Cool Renewal | GEH | Substantially Equivalent | Cool Renewal, LLC | accessdata.fda.gov |
Compare with other makers
Updated July 6, 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.