Cleared Traditional

SeptAlign

K233569 · Spirair, Inc. · Ear, Nose, Throat
Mar 2024
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K233569 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 March 22, 2024, 137 days after receiving the submission on November 6, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K233569 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2023
Decision Date March 22, 2024
Days to Decision 137 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.