Cleared Traditional

AHMED ClearPath Glaucoma Drainage Device

K182518 · New World Medical, Inc. · Ophthalmic
Jan 2019
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K182518 is an FDA 510(k) clearance for the AHMED ClearPath Glaucoma Drainage Device, 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 January 18, 2019, 127 days after receiving the submission on September 13, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3920.

Submission Details

510(k) Number K182518 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2018
Decision Date January 18, 2019
Days to Decision 127 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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