510(k) K163586
K163586 is an FDA 510(k) premarket notification submitted by Trovrx, Inc. Dba Trovita Health Science for the device "Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector". The FDA issued a decision of Substantially Equivalent on Mar 17, 2017. The device falls under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 17, 2017
- Date Received
- Dec 20, 2016
- 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
- 510(k)
To facilitate enteral specific connections.