Cleared Special

MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER

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

About This 510(k) Submission

K093594 is an FDA 510(k) clearance for the MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER, a Cannula, Sinus (Class I — General Controls, product code KAM), submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Cleared decision on March 3, 2010, 104 days after receiving the submission on November 19, 2009. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K093594 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KAM — Cannula, Sinus
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800