Cleared Special

PATHASSIST LIGHT FIBER

K120962 · Entellus Medical, Inc. · Ear, Nose, Throat
Apr 2012
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K120962 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 April 27, 2012, 28 days after receiving the submission on March 30, 2012. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K120962 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2012
Decision Date April 27, 2012
Days to Decision 28 days
Submission Type Special
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