510(k) K123716

AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT by Applied Medical Technology, Inc. — Product Code KNT

K123716 is an FDA 510(k) premarket notification submitted by Applied Medical Technology, Inc. for the device "AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT". The FDA issued a decision of Substantially Equivalent (kit) on April 19, 2013. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Applied Medical Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
April 19, 2013
Date Received
December 4, 2012
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