Cleared Special

PATHASSIST LED LIGHT FIBER

K141916 · Entellus Medical, Inc. · Ear, Nose, Throat
Aug 2014
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K141916 is an FDA 510(k) clearance for the PATHASSIST LED LIGHT FIBER, 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 August 7, 2014, 23 days after receiving the submission on July 15, 2014. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K141916 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2014
Decision Date August 07, 2014
Days to Decision 23 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