Cleared Special

TULA Iontophoresis System with Earset

K150453 · Acclarent, Inc. · Physical Medicine
May 2015
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K150453 is an FDA 510(k) clearance for the TULA Iontophoresis System with Earset, a Device, Iontophoresis, Other Uses (Class II — Special Controls, product code EGJ), submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Cleared decision on May 20, 2015, 89 days after receiving the submission on February 20, 2015. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5525.

Submission Details

510(k) Number K150453 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2015
Decision Date May 20, 2015
Days to Decision 89 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code EGJ — Device, Iontophoresis, Other Uses
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5525

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