Cleared Traditional

XPRESS BALLOON DEVICE

K102003 · Entellus Medical, Inc. · Ear, Nose, Throat
Oct 2010
Decision
99d
Days
Class 1
Risk

About This 510(k) Submission

K102003 is an FDA 510(k) clearance for the XPRESS BALLOON DEVICE, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Entellus Medical, Inc. (Maple Grove, US). The FDA issued a Cleared decision on October 22, 2010, 99 days after receiving the submission on July 15, 2010. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K102003 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2010
Decision Date October 22, 2010
Days to Decision 99 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LRC — Instrument, Ent Manual Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4420