Cleared Traditional

K110636 - TULA IONTOPHORESIS SYSTEM

K110636 is an FDA 510(k) clearance for TULA IONTOPHORESIS SYSTEM, manufactured by Acclarent, Inc.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K110636 · Acclarent, Inc. · Physical Medicine device
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Jun 2011
Decision
104d
Days
Class 2
Risk

K110636 is an FDA 510(k) clearance for the TULA IONTOPHORESIS SYSTEM. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Cleared decision on June 16, 2011 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5525 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Acclarent, Inc. devices

FDA 510(k) Submission Details - K110636

510(k) Number K110636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2011
Decision Date June 16, 2011
Days to Decision 104 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
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
Predicate-based equivalence. No clinical trials required.

EGJ Device Classification - Class 2, Special Controls

Product Code EGJ Device, Iontophoresis, Other Uses
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5525
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - EGJ Device, Iontophoresis, Other Uses

All 48
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K110636.
TULA Iontophoresis System with Earset
K150453 · Acclarent, Inc. · May 2015
HIDREX PSP1000
K133033 · Hidrex GmbH · Apr 2015
ACTIVAPATCH ET IONTOPHORESIS PATCH
K132832 · Activatek, Inc. · Feb 2014
IONTOPHORESIS SYSTEM
K073276 · Acclarent, Inc. · Mar 2008
HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
K072946 · Empi · Nov 2007
DUPEL TRANSPORT IONTOPHORESIS SYSTEM
K070427 · Empi · May 2007