Cleared Traditional

Spirair Nasal Septal Strap

K223167 · Spirair, Inc. · Ear, Nose, Throat
Aug 2023
Decision
314d
Days
Class 2
Risk

About This 510(k) Submission

K223167 is an FDA 510(k) clearance for the Spirair Nasal Septal Strap, a Polymer, Ear, Nose And Throat, Synthetic, Absorbable (Class II — Special Controls, product code NHB), submitted by Spirair, Inc. (San Jose, US). The FDA issued a Cleared decision on August 17, 2023, 314 days after receiving the submission on October 7, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K223167 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2022
Decision Date August 17, 2023
Days to Decision 314 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.