Gabriel 3 Way EnFit Valve— 510(k) K201741
Substantially EquivalentSyncro Medical Innovations, Inc.
FDA 510(k) clearance K201741 for Gabriel 3 Way EnFit Valve, Substantially Equivalent on 2020-11-05. Applicant: Syncro Medical Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Syncro Medical Innovations, Inc.
- Product code
- Code PIF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Macon, GA, US
Recent devices under product code PIF
view allMore clearances from Syncro Medical Innovations, Inc.
view all- 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
- K072787 — GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111
- K021991 — MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE
Adverse events under product code PIF
product code PIF- Death
- 13
- Injury
- 122
- Other
- 1
- Total
- 136
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.