510(k) K201741
K201741 is an FDA 510(k) premarket notification submitted by Syncro Medical Innovations, Inc. for the device "Gabriel 3 Way EnFit Valve". The FDA issued a decision of Substantially Equivalent on November 5, 2020. 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
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 2020
- Date Received
- June 25, 2020
- 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.