510(k) K191759
K191759 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "Medline Quick Switch Valve with ENFit Connector". The FDA issued a decision of Substantially Equivalent on Dec 4, 2019. The device falls under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Medline Industries, Inc. has 268 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 4, 2019
- Date Received
- Jul 1, 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
- 510(k)
To facilitate enteral specific connections.