510(k) K201322

Entuit Nasal Jejunal Feeding Tube by Wilson-Cook Medical, Inc. — Product Code KNT

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