510(k) K120587

AMT T-FASTENER ANCHOR KIT by Applied Medical Technology, Inc. — Product Code KGC

K120587 is an FDA 510(k) premarket notification submitted by Applied Medical Technology, Inc. for the device "AMT T-FASTENER ANCHOR KIT". The FDA issued a decision of Substantially Equivalent (kit) on May 25, 2012. The device falls under product code KGC (Tube, Gastro-Enterostomy), 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
May 25, 2012
Date Received
February 27, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Gastro-Enterostomy
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type