510(k) K182804

Traditional Length GJ Feeding Device by Applied Medical Technology, Inc. — Product Code KNT

K182804 is an FDA 510(k) premarket notification submitted by Applied Medical Technology, Inc. for the device "Traditional Length GJ Feeding Device". The FDA issued a decision of Substantially Equivalent on March 1, 2019. 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
SESE (Substantially Equivalent)
Decision Date
March 1, 2019
Date Received
October 2, 2018
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