Cleared Traditional

Novapak Nasal Sinus Packing and Stent

K202623 · Medtronic Xomed · Ear, Nose, Throat

Dec 2020

Decision

89d

Days

Class 1

Risk

About This 510(k) Submission

K202623 is an FDA 510(k) clearance for the Novapak Nasal Sinus Packing and Stent, a Splint, Intranasal Septal (Class I — General Controls, product code LYA), submitted by Medtronic Xomed (Jacksonville, US). The FDA issued a Cleared decision on December 8, 2020, 89 days after receiving the submission on September 10, 2020. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4780.

Submission Details

510(k) Number	K202623 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2020
Decision Date	December 08, 2020
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF