510(k) K172537

Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag by Codman & Shurtleff, Inc. — Product Code JXG

K172537 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag". The FDA issued a decision of Substantially Equivalent on October 16, 2017. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.