Cleared Special

Ahmed? Glaucoma Valve Model FP7

K230975 · New World Medical, Inc. · Ophthalmic
May 2023
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K230975 is an FDA 510(k) clearance for the Ahmed? Glaucoma Valve Model FP7, 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 May 12, 2023, 37 days after receiving the submission on April 5, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3920.

Submission Details

510(k) Number K230975 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 2023
Decision Date May 12, 2023
Days to Decision 37 days
Submission Type Special
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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