Cleared Traditional

TurbAlign

K243655 · Spirair, Inc. · Ear, Nose, Throat
Jul 2025
Decision
227d
Days
Class 1
Risk

About This 510(k) Submission

K243655 is an FDA 510(k) clearance for the TurbAlign, a Splint, Intranasal Septal (Class I — General Controls, product code LYA), submitted by Spirair, Inc. (South San Francisco, US). The FDA issued a Cleared decision on July 11, 2025, 227 days after receiving the submission on November 26, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4780.

Submission Details

510(k) Number K243655 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2024
Decision Date July 11, 2025
Days to Decision 227 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