Syncro Medical Innovations, Inc.
Macon, GA, US
SYNCRO MEDICAL INNOVATIONS, INC. appears in FDA device records in Macon, GA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Syncro Medical Innovations, Inc. between 2002 and 2020. The busiest year on record is 2002, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2007 | 1 |
| 2011 | 1 |
| 2016 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201741 | Gabriel 3 Way EnFit Valve | PIF | Substantially Equivalent | |
| K191784 | Gabriel Feeding Tube with Balloon, and EnFit Connector | PIF | Unknown | |
| K160787 | Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet | KNT | Unknown | |
| K110005 | SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE | KNT | Unknown | |
| K072787 | GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111 | KNT | Substantially Equivalent | |
| K021991 | MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE | KNT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1066607 | 3003282547 | SYNCRO MEDICAL INNOVATIONS, INC. | 101 Gateway Dr, Macon, GA 31210 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain