Cleared Special

K093594 - MODIFICATION TO RELIEVA STRATUS MICROFL...

K093594 is the FDA 510(k) clearance for MODIFICATION TO RELIEVA STRATUS MICROFL... by Acclarent, Inc.. It is a Class 1 General & Plastic Surgery device (product code KAM) cleared through the Special 510(k) pathway after a 104-day FDA review.

K093594 · Acclarent, Inc. · General & Plastic Surgery device
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Mar 2010
Decision
104d
Days
Class 1
Risk

K093594 is an FDA 510(k) clearance for the MODIFICATION TO RELIEVA STRATUS MICROFLOW 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 March 3, 2010 after a review of 104 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Acclarent, Inc. devices

Submission Details

510(k) Number K093594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2009
Decision Date March 03, 2010
Days to Decision 104 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
11d faster than avg
Panel avg: 115d · This submission: 104d
Pathway characteristics
Modification to existing cleared device.

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 K093594.
RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
K110687 · Acclarent, Inc. · Oct 2011
RELIEVA STRATUS MICROFLOW SPACER
K083574 · Acclarent, Inc. · Jan 2009
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
ETHMOID SINUS SPACER
K062458 · Acclarent, Inc. · Sep 2006