Cleared Traditional

K130503 - PATHASSIST LED LIGHT FIBER

K130503 is an FDA 510(k) clearance for PATHASSIST LED LIGHT FIBER, manufactured by Entellus Medical, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LRC cleared through the Traditional 510(k) pathway after a 104-day FDA review.

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

K130503 is an FDA 510(k) clearance for the PATHASSIST LED LIGHT FIBER. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Entellus Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on June 11, 2013 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Entellus Medical, Inc. devices

FDA 510(k) Submission Details - K130503

510(k) Number K130503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 89d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

LRC Device Classification - Class 1, General Controls

Product Code LRC Instrument, Ent Manual Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LRC Instrument, Ent Manual Surgical

All 54
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