510(k) K201322
K201322 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Entuit Nasal Jejunal Feeding Tube". The FDA issued a decision of Substantially Equivalent (kit) on June 17, 2020. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- June 17, 2020
- Date Received
- May 18, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type