510(k) K160509

Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube by Cook Incorporated — Product Code KNT

K160509 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube". The FDA issued a decision of Substantially Equivalent - Kit on May 18, 2017. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Cook Incorporated has 174 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent - Kit)
Decision Date
May 18, 2017
Date Received
Feb 24, 2016
Clearance Type
Traditional
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
510(k)