Data / Medical devices / United States / Fettech
Fettech: FDA-registered device maker in Davie, FL, United States, 2 510(k) clearances
Fettech is registered with the FDA (registration 3014498807) in Davie, FL, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 19, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014498807
- Address
- 12040 Ashford Ln, Davie, FL, United States, 33325
- Owner or operator
- FetTech (10088070)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 22, 2023
- Registered through
- 2026
- Brand names listed
- REYAGEL, XCelliStem
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wound Dressing With Animal-Derived Material(S) | KGN | U | 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 19, 2024 | K232204 | ReyaGel (RG03 - MTP gel 3mL) | KGN | Substantially Equivalent | Fettech | accessdata.fda.gov |
| March 16, 2018 | K172593 | XCelliStem Wound Powder | KGN | Substantially Equivalent | Stemsys | accessdata.fda.gov |
Compare with other makers
Updated April 19, 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.