Cleared Special

PATHASSIST LIGHT SEEKER

K113522 · Entellus Medical, Inc. · Ear, Nose, Throat
Jan 2012
Decision
59d
Days
Class 1
Risk

About This 510(k) Submission

K113522 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. (Maple Grove, US). The FDA issued a Cleared decision on January 27, 2012, 59 days after receiving the submission on November 29, 2011. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K113522 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2011
Decision Date January 27, 2012
Days to Decision 59 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