Cleared Traditional

K072302 - ENTELLUS MEDICAL RS-SERIES SYSTEM

K072302 is an FDA 510(k) clearance for ENTELLUS MEDICAL RS-SERIES SYSTEM, 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 235-day FDA review.

K072302 · Entellus Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
235d
Days
Class 1
Risk

K072302 is an FDA 510(k) clearance for the ENTELLUS MEDICAL RS-SERIES SYSTEM. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Entellus Medical, Inc. (Maple Grove, US). The FDA issued a Cleared decision on April 8, 2008 after a review of 235 days - an extended review 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. 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 - K072302

510(k) Number K072302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2007
Decision Date April 08, 2008
Days to Decision 235 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
146d slower than avg
Panel avg: 89d · This submission: 235d
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
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K072302.
ENTELLUS MEDICAL BALLOON DEVICE
K093007 · Entellus Medical, Inc. · Feb 2010
FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)
K091681 · Entellus Medical, Inc. · Jul 2009
MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM
K081542 · Entellus Medical, Inc. · Jun 2008
RELIEVA SINUS BALLOON CATHETER
K061903 · Acclarent, Inc. · Aug 2006
RELIEVA SINUS BALLOON INFLATION DEVICE
K052198 · Acclarent, Inc. · Aug 2005
EXMOOR SUCTION CLEARANCE KIT
K990366 · Exmoor Plastics , Ltd. · Mar 1999