Cleared Special

SPIWay Endonasal Access Guide

K180141 · Spiway, LLC · Ear, Nose, Throat
Feb 2018
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K180141 is an FDA 510(k) clearance for the SPIWay Endonasal Access Guide, a Splint, Intranasal Septal (Class I — General Controls, product code LYA), submitted by Spiway, LLC (Carlsbad, US). The FDA issued a Cleared decision on February 16, 2018, 29 days after receiving the submission on January 18, 2018. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4780.

Submission Details

510(k) Number K180141 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2018
Decision Date February 16, 2018
Days to Decision 29 days
Submission Type Special
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