Cleared Traditional

PATHASSIST LED LIGHT FIBER

K130503 · Entellus Medical, Inc. · Ear, Nose, Throat
Jun 2013
Decision
104d
Days
Class 1
Risk

About This 510(k) Submission

K130503 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 June 11, 2013, 104 days after receiving the submission on February 27, 2013. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K130503 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2013
Decision Date June 11, 2013
Days to Decision 104 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