510(k) K170162
K170162 is an FDA 510(k) premarket notification submitted by Vesco Medical, LLC for the device "Vesco Medical Nasoenteric Feeding Tubes". The FDA issued a decision of Substantially Equivalent on September 26, 2017. The device falls under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Vesco Medical, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2017
- Date Received
- January 18, 2017
- 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.