Data / Medical devices / United States / Syncro Medical Innovations, Inc.
Syncro Medical Innovations, Inc.: FDA-registered device maker in Macon, GA, United States, 3 510(k) clearances
Syncro Medical Innovations, Inc. is registered with the FDA (registration 1066607) in Macon, GA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 5, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1066607
- FEI number
- 3003282547
- Address
- 101 Gateway Dr, Macon, GA, United States, 31210
- Owner or operator
- SYNCRO MEDICAL INNOVATIONS, INC. (9045267)
- Roles
- Specification developer
- First device listed
- November 3, 2016
- Registered through
- 2026
- Brand names listed
- Gabriel 3-Way EnFit Valve, Gabriel Feeding Tube with Balloon, Gabriel Feeding Tube with Balloon, and EnFit Connector, Gabriel® Urine Bag
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Urine Collecting, Ureterostomy | EXG | 1 | Specification developer | accessdata.fda.gov |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | 2 | Specification developer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | 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 |
|---|---|---|---|---|---|---|
| November 5, 2020 | K201741 | Gabriel 3 Way EnFit Valve | PIF | Substantially Equivalent | Syncro Medical Innovations, Inc. | accessdata.fda.gov |
| November 15, 2019 | K191784 | Gabriel Feeding Tube with Balloon, and EnFit Connector | PIF | Unknown | Syncro Medical Innovations, Inc. | accessdata.fda.gov |
| August 9, 2016 | K160787 | Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet | KNT | Unknown | Syncro Medical Innovations, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Gastrointestinal Tubes With Enteral Specific Connectors
- All makers of Bag, Urine Collecting, Ureterostomy
- All makers of Tubes, Gastrointestinal (And Accessories)
Updated November 5, 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.