Cleared Traditional

ChitoZolve

K181696 · Gyrus Acmi, Inc. · Ear, Nose, Throat
Nov 2018
Decision
156d
Days
Class 1
Risk

About This 510(k) Submission

K181696 is an FDA 510(k) clearance for the ChitoZolve, a Splint, Intranasal Septal (Class I — General Controls, product code LYA), submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on November 30, 2018, 156 days after receiving the submission on June 27, 2018. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4780.

Submission Details

510(k) Number K181696 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2018
Decision Date November 30, 2018
Days to Decision 156 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LYA — Splint, Intranasal Septal
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4780

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