Cleared Special

LATERA Absorbable Nasal Implant System

K192661 · Entellus Medical, Inc. (Aka Stryker Ent) · Ear, Nose, Throat

Nov 2019

Decision

46d

Days

Class 2

Risk

About This 510(k) Submission

K192661 is an FDA 510(k) clearance for the LATERA Absorbable Nasal Implant System, a Polymer, Ear, Nose And Throat, Synthetic, Absorbable (Class II — Special Controls, product code NHB), submitted by Entellus Medical, Inc. (Aka Stryker Ent) (Plymouth, US). The FDA issued a Cleared decision on November 10, 2019, 46 days after receiving the submission on September 25, 2019. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number	K192661 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 2019
Decision Date	November 10, 2019
Days to Decision	46 days
Submission Type	Special
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.