Cleared Traditional

K121351 - SINUS DILATION SYSTEM

K121351 is an FDA 510(k) clearance for SINUS DILATION SYSTEM, manufactured by Entrigue Surgical, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LRC cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K121351 · Entrigue Surgical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
117d
Days
Class 1
Risk

K121351 is an FDA 510(k) clearance for the SINUS DILATION SYSTEM. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Entrigue Surgical, Inc. (San Antonio, US). The FDA issued a Cleared decision on August 29, 2012 after a review of 117 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 Entrigue Surgical, Inc. devices

FDA 510(k) Submission Details - K121351

510(k) Number K121351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2012
Decision Date August 29, 2012
Days to Decision 117 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 89d · This submission: 117d
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 55
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K121351.
XPRESS MULTI-SINUS DILATION TOOL
K132440 · Entellus Medical, Inc. · 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
XPRESS MULTI-SINUS DILATION TOOL
K121174 · Entellus Medical, Inc. · May 2012
PATHASSIST LIGHT FIBER
K120962 · Entellus Medical, Inc. · Apr 2012