Cleared Traditional

Ahmed Glaucoma Valve

K162060 · New World Medical, Inc. · Ophthalmic
Oct 2016
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K162060 is an FDA 510(k) clearance for the Ahmed Glaucoma Valve, a Implant, Eye Valve (Class II — Special Controls, product code KYF), submitted by New World Medical, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on October 24, 2016, 90 days after receiving the submission on July 26, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3920.

Submission Details

510(k) Number K162060 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2016
Decision Date October 24, 2016
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code KYF — Implant, Eye Valve
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.3920

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