Cleared Special

MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER (K093594) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K093594 · Acclarent, Inc. · General & Plastic Surgery device
Download Printable Device Report (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.

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
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.