510(k) K172266

Dynarex Three-Way Stopcock by Dynarex Corporation — Product Code FMG

K172266 is an FDA 510(k) premarket notification submitted by Dynarex Corporation for the device "Dynarex Three-Way Stopcock". The FDA issued a decision of Substantially Equivalent on March 14, 2018. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Dynarex Corporation has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2018
Date Received
July 27, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stopcock, I.V. Set
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type