510(k) K191784
K191784 is an FDA 510(k) premarket notification submitted by Syncro Medical Innovations, Inc. for the device "Gabriel Feeding Tube with Balloon, and EnFit Connector". The FDA issued a decision of Substantially Equivalent (kit, denovo) on November 15, 2019. The device falls under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Syncro Medical Innovations, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- November 15, 2019
- Date Received
- July 3, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastrointestinal Tubes With Enteral Specific Connectors
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
To facilitate enteral specific connections.