510(k) K131183

MED-RX ORAL/ENTERAL SYRINGE by Benlan, Inc. — Product Code KNT

K131183 is an FDA 510(k) premarket notification submitted by Benlan, Inc. for the device "MED-RX ORAL/ENTERAL SYRINGE". The FDA issued a decision of Substantially Equivalent on June 3, 2014. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Benlan, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2014
Date Received
April 26, 2013
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