510(k) K113351

CORTRAK ENTERAL ACCESS DEVICE by Corpak Medsystems — Product Code KNT

K113351 is an FDA 510(k) premarket notification submitted by Corpak Medsystems for the device "CORTRAK ENTERAL ACCESS DEVICE". The FDA issued a decision of Substantially Equivalent on January 10, 2012. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Corpak Medsystems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2012
Date Received
November 14, 2011
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