510(k) K210971
K210971 is an FDA 510(k) premarket notification submitted by Vonco Products for the device "EnteraLoc Flow". The FDA issued a decision of Substantially Equivalent on August 18, 2021. The device falls under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Vonco Products has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2021
- Date Received
- March 31, 2021
- 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.