Cleared Special

PATHASSIST LIGHT SEEKER

K133563 · Entellus Medical, Inc. · Ear, Nose, Throat
Dec 2013
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K133563 is an FDA 510(k) clearance for the PATHASSIST LIGHT SEEKER, 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 December 20, 2013, 30 days after receiving the submission on November 20, 2013. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K133563 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2013
Decision Date December 20, 2013
Days to Decision 30 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