GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111— 510(k) K072787
Substantially EquivalentSyncro Medical Innovations, Inc.
FDA 510(k) clearance K072787 for GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111, Substantially Equivalent on 2007-10-31. Applicant: Syncro Medical Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Syncro Medical Innovations, Inc.
- Product code
- Code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Leola, PA, US
Recent devices under product code KNT
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view all- K201741 — Gabriel 3 Way EnFit Valve
- K191784 — Gabriel Feeding Tube with Balloon, and EnFit Connector
- K160787 — Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet
- K110005 — SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE
- K021991 — MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE
Adverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.