Cleared Traditional

PassAssist LED Light Fiber

K152435 · Entellus Medical, Inc. · Ear, Nose, Throat
Nov 2015
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K152435 is an FDA 510(k) clearance for the PassAssist 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 November 20, 2015, 85 days after receiving the submission on August 27, 2015. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K152435 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2015
Decision Date November 20, 2015
Days to Decision 85 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