Cleared Special

K093594 - MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER

K093594 is an FDA 510(k) clearance for MODIFICATION TO RELIEVA STRATUS MICROFL..., 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 104-day FDA review.

K093594 · Acclarent, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K093594

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.

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 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
K093594 · MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
Download PDF FDA Summary Acclarent, Inc.