510(k) K231051

Ahmed® Glaucoma Valve Model FP8 by New World Medical, Inc. — Product Code KYF

K231051 is an FDA 510(k) premarket notification submitted by New World Medical, Inc. for the device "Ahmed® Glaucoma Valve Model FP8". The FDA issued a decision of Substantially Equivalent on May 12, 2023. 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
May 12, 2023
Date Received
April 13, 2023
Clearance Type
Special
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