Cleared Special

K060974 - RELIENT NAVIGATION DEVICE

K060974 is an FDA 510(k) clearance for RELIENT NAVIGATION DEVICE, manufactured by Acclarent, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KAM cleared through the Special 510(k) pathway after a 25-day FDA review.

K060974 · Acclarent, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
25d
Days
Class 1
Risk

K060974 is an FDA 510(k) clearance for the RELIENT NAVIGATION DEVICE. 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 May 5, 2006 after a review of 25 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. 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.

FDA 510(k) Submission Details - K060974

510(k) Number K060974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2006
Decision Date May 05, 2006
Days to Decision 25 days
Submission Type Special
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
90d faster than avg
Panel avg: 115d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

KAM Device Classification - Class 1, General Controls

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 18
Devices cleared under the same product code (KAM) and FDA review panel - the closest regulatory comparables to K060974.
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
ETHMOID SINUS SPACER
K062458 · Acclarent, Inc. · Sep 2006
MICROMEDICS SPHENOID SINUS STENT
K050340 · Micromedics, Inc. · Apr 2005
FRONTAL SINUS TREPHINATION CANNULA
K994262 · Xomed, Inc. · Feb 2000
XOMED T-STENT, FRONTAL SINUS STENT
K973273 · Xomed, Inc. · Sep 1997
K060974 · RELIENT NAVIGATION DEVICE
Download PDF FDA Summary Acclarent, Inc.