Data / Medical devices / United States / Med-Fibers, Inc.
Med-Fibers, Inc.: FDA-registered device maker in Chandler, AZ, United States, 1 510(k) clearance
Med-Fibers, Inc. is registered with the FDA (registration 3010035831) in Chandler, AZ, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 17, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010035831
- Address
- 7404 W Detroit St Ste 140, Chandler, AZ, United States, 85226
- Owner or operator
- MED-Fibers, Inc. (10043263)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- January 31, 2013
- Registered through
- 2026
- Brand names listed
- Aspirating Endo Probes, Dome Tip Fibers (TM), Easy Flex Glide Fibers (TM), Endo Probes, Endo-ENT Probes, MF-Bas-1.5F-4W-120CM-NTL, MF-Bas-1.7F-4W-120CM-NTL, MF-Bas-1.9F-4W-120CM-NTL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| January 17, 2013 | K124003 | MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE | GEX | Substantially Equivalent | Med-Fibers, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Dislodger, Stone, Basket, Ureteral, Metal
Updated January 17, 2013. 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.