510(k) K200082
K200082 is an FDA 510(k) premarket notification submitted by Mps Medical, Inc. for the device "BD Univia RightFit Enteral Extension Sets and Transitional Adapters". The FDA issued a decision of Substantially Equivalent on Jul 30, 2020. 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
- Jul 30, 2020
- Date Received
- Jan 15, 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
- 510(k)
To facilitate enteral specific connections.