Cleared Special

SPIWay Endonasal Access Guide

K213153 · Spiway, LLC · Ear, Nose, Throat
Oct 2021
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K213153 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 October 27, 2021, 29 days after receiving the submission on September 28, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4780.

Submission Details

510(k) Number K213153 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2021
Decision Date October 27, 2021
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