Cleared Traditional

ENTELLUS MEDICAL BALLOON DEVICE

K093007 · Entellus Medical, Inc. · Ear, Nose, Throat
Feb 2010
Decision
130d
Days
Class 1
Risk

About This 510(k) Submission

K093007 is an FDA 510(k) clearance for the ENTELLUS MEDICAL BALLOON DEVICE, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Entellus Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on February 5, 2010, 130 days after receiving the submission on September 28, 2009. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K093007 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2009
Decision Date February 05, 2010
Days to Decision 130 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