Cleared Traditional

K062458 - ETHMOID SINUS SPACER

K062458 is the FDA 510(k) clearance for ETHMOID SINUS SPACER by Acclarent, Inc.. It is a Class 1 General & Plastic Surgery device (product code KAM) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K062458 · Acclarent, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
23d
Days
Class 1
Risk

K062458 is an FDA 510(k) clearance for the ETHMOID SINUS SPACER. Classified as Cannula, Sinus (product code KAM), Class I - General Controls.

Submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Cleared decision on September 15, 2006 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Acclarent, Inc. devices

Submission Details

510(k) Number K062458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2006
Decision Date September 15, 2006
Days to Decision 23 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KAM Cannula, Sinus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - KAM Cannula, Sinus

All 12
Devices cleared under the same product code (KAM) and FDA review panel - the closest regulatory comparables to K062458.
SINUS SPACER
K072891 · Acclarent, Inc. · Mar 2008
RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
K073041 · Acclarent, Inc. · Mar 2008
RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A
K071845 · Acclarent, Inc. · Sep 2007
RELIENT NAVIGATION DEVICE
K060974 · Acclarent, Inc. · May 2006
FRONTAL SINUS TREPHINATION CANNULA
K994262 · Xomed, Inc. · Feb 2000
XOMED T-STENT, FRONTAL SINUS STENT
K973273 · Xomed, Inc. · Sep 1997