Cleared Special

K132440 - XPRESS MULTI-SINUS DILATION TOOL

K132440 is an FDA 510(k) clearance for XPRESS MULTI-SINUS DILATION TOOL, manufactured by Entellus Medical, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LRC cleared through the Special 510(k) pathway after a 59-day FDA review.

K132440 · Entellus Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
59d
Days
Class 1
Risk

K132440 is an FDA 510(k) clearance for the XPRESS MULTI-SINUS DILATION TOOL. 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 October 4, 2013 after a review of 59 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Entellus Medical, Inc. devices

FDA 510(k) Submission Details - K132440

510(k) Number K132440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2013
Decision Date October 04, 2013
Days to Decision 59 days
Submission Type Special
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
30d faster than avg
Panel avg: 89d · This submission: 59d
Pathway characteristics
Modification to existing cleared device.

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
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K132440.
PATHASSIST LIGHT SEEKER
K133563 · Entellus Medical, Inc. · Dec 2013
EM SINUS DILATION SYSTEM
K132297 · Medtronic Xomed, Inc. · Nov 2013
SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT
K131709 · Arthrocare Corp. · Oct 2013
PATHASSIST LED LIGHT FIBER
K130503 · Entellus Medical, Inc. · Jun 2013
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM
K120280 · Acclarent, Inc. · Nov 2012
XPRESS MULTI-SINUS DILATION TOOL
K121943 · Entellus Medical, Inc. · Aug 2012