Cleared Traditional

SINUSPRIME Dilation System

K201398 · Stryker Ent · Ear, Nose, Throat

Oct 2020

Decision

140d

Days

Class 1

Risk

About This 510(k) Submission

K201398 is an FDA 510(k) clearance for the SINUSPRIME Dilation System, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Stryker Ent (Plymouth, US). The FDA issued a Cleared decision on October 15, 2020, 140 days after receiving the submission on May 28, 2020. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number	K201398 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 28, 2020
Decision Date	October 15, 2020
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF