Cleared Traditional

DSS Sinusplasty Balloon Catheter

K143738 · Intuit Medical Products, LLC · Ear, Nose, Throat

Aug 2015

Decision

240d

Days

Class 1

Risk

About This 510(k) Submission

K143738 is an FDA 510(k) clearance for the DSS Sinusplasty Balloon Catheter, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Intuit Medical Products, LLC (Sugar Hill, US). The FDA issued a Cleared decision on August 27, 2015, 240 days after receiving the submission on December 30, 2014. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number	K143738 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 30, 2014
Decision Date	August 27, 2015
Days to Decision	240 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF