Cleared Traditional

SeptAlign

K251790 · Spirair, Inc. · Ear, Nose, Throat

Jan 2026

Decision

219d

Days

Class 2

Risk

About This 510(k) Submission

K251790 is an FDA 510(k) clearance for the SeptAlign, a Polymer, Ear, Nose And Throat, Synthetic, Absorbable (Class II — Special Controls, product code NHB), submitted by Spirair, Inc. (South San Francisco, US). The FDA issued a Cleared decision on January 16, 2026, 219 days after receiving the submission on June 11, 2025. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number	K251790 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 2025
Decision Date	January 16, 2026
Days to Decision	219 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	NHB — Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.3620
Definition	Ear, Nose, And Throat Absorbable Synthetic Polymer Material Is A Device Material That Is Intended To Be Implanted For Use As A Space-occupying Substance In The Reconstructive Surgery Of The Head And Neck. The Device Is Shaped And Formed By The Surgeon To Conform To The Patient's Needs. This Generic Type Of Device Is Made Of Absorbable Synthetic Polymer Materials.