Data / Medical devices / United States / Fabinject LLC
Fabinject LLC: FDA-registered device maker in Winter Park, FL, United States, 1 510(k) clearance
Fabinject LLC is registered with the FDA (registration 3030979014) in Winter Park, FL, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 18, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030979014
- Address
- 7006 Stapoint Ct Ste I, Winter Park, FL, United States, 32792
- Owner or operator
- Fabinject LLC (10090611)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- April 18, 2024
- Registered through
- 2026
- Brand names listed
- B 15G-100, B 15G-110, B 15G-30, B 15G-50, B 15G-70, B 15G-80, B 16G-100, B 16G-110 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Transilluminator, Battery-Powered | HJN | 1 | Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| October 18, 2024 | K242132 | FREDDO | GEX | Substantially Equivalent | Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Transilluminator, Battery-Powered
- All makers of Cannula, Surgical, General & Plastic Surgery
- All makers of Pack, Hot Or Cold, Reusable
Updated October 18, 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.