Cleared Traditional

K160770 - Vent-Os Sinus Dilation family

K160770 is an FDA 510(k) clearance for Vent-Os Sinus Dilation family, manufactured by Sinusys Corporation. The device is a Class 1 Ear, Nose, Throat device with product code LRC cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K160770 · Sinusys Corporation · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
100d
Days
Class 1
Risk

K160770 is an FDA 510(k) clearance for the Vent-Os Sinus Dilation family. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Sinusys Corporation (Palo Alto, US). The FDA issued a Cleared decision on June 29, 2016 after a review of 100 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 Sinusys Corporation devices

FDA 510(k) Submission Details - K160770

510(k) Number K160770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2016
Decision Date June 29, 2016
Days to Decision 100 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
10d slower than avg
Panel avg: 90d · This submission: 100d
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.

Clinical Evidence

ClinicalTrials.gov
NCT02463279 Completed Interventional Industry-sponsored

SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study

30
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Sinusitis
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Jerome Hester, MD
Sponsor SinuSys Corporation (industry)
Started 2015-04-01 → Primary completion 2015-10-01 → Completed 2016-03-01
Primary outcome
Patency of treated target site
Secondary outcome
Patency of treated target site
Study completed - no results published. This trial concluded in 2016 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - LRC Instrument, Ent Manual Surgical

All 62
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K160770.
MESIRE - Balloon Sinus Dilatation System
K172737 · M/S. Meril Life Sciences Private Limited · Dec 2017
Relieva SpinPlus Nav Balloon Sinuplasty System
K171687 · Acclarent, Inc. · Sep 2017
Relieva UltirraNav Sinus Balloon Catheter
K161698 · Acclarent, Inc. · Oct 2016
Relieva Scout Multi-Sinus Dilation System
K153341 · Acclarent, Inc. · Feb 2016
NuVent EM Sinus Dilation System
K152121 · Medtronic Xomed, Inc. · Dec 2015
XprESS Multi-Sinus Dilation System
K152434 · Entellus Medical, Inc. · Nov 2015