Cleared Traditional

PATHASSIST LIGHT FIBER

K111763 · Entellus Medical, Inc. · Ear, Nose, Throat
Sep 2011
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K111763 is an FDA 510(k) clearance for the PATHASSIST LIGHT FIBER, 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 September 15, 2011, 84 days after receiving the submission on June 23, 2011. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K111763 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2011
Decision Date September 15, 2011
Days to Decision 84 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