510(k) K182518

AHMED ClearPath Glaucoma Drainage Device by New World Medical, Inc. — Product Code KYF

K182518 is an FDA 510(k) premarket notification submitted by New World Medical, Inc. for the device "AHMED ClearPath Glaucoma Drainage Device". The FDA issued a decision of Substantially Equivalent on January 18, 2019. The device falls under product code KYF (Implant, Eye Valve), a Class II device regulated under 21 CFR 886.3920. New World Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2019
Date Received
September 13, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Eye Valve
Device Class
Class II
Regulation Number
886.3920
Review Panel
OP
Submission Type