Cleared Special

SPIWay Endonasal Access Guide

K153686 · Spiway, LLC · Ear, Nose, Throat
Jan 2016
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K153686 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 (San Clemente, US). The FDA issued a Cleared decision on January 28, 2016, 36 days after receiving the submission on December 23, 2015. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4780.

Submission Details

510(k) Number K153686 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2015
Decision Date January 28, 2016
Days to Decision 36 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