Cleared Traditional

Kahook Dual Blade Glide (KDB Glide)

K220891 · New World Medical, Inc. · Ophthalmic
May 2024
Decision
781d
Days
Class 2
Risk

About This 510(k) Submission

K220891 is an FDA 510(k) clearance for the Kahook Dual Blade Glide (KDB Glide), a Knife, Intraocular Pressure Lowering (Class II — Special Controls, product code QUQ), submitted by New World Medical, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on May 17, 2024, 781 days after receiving the submission on March 28, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K220891 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2022
Decision Date May 17, 2024
Days to Decision 781 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code QUQ — Knife, Intraocular Pressure Lowering
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4400
Definition A Knife Intended For Cutting Of Trabecular Meshwork To Reduce Intraocular Pressure In Glaucoma