Cleared Special

K171239 - TULA Tube Delivery System

K171239 is an FDA 510(k) clearance for TULA Tube Delivery System, manufactured by Tusker Medical. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Special 510(k) pathway after a 62-day FDA review.

K171239 · Tusker Medical · Ear, Nose, Throat device
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Jun 2017
Decision
62d
Days
Class 2
Risk

K171239 is an FDA 510(k) clearance for the TULA Tube Delivery System. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Tusker Medical (Menlo Park, US). The FDA issued a Cleared decision on June 28, 2017 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3880 - the FDA ear, nose and throat 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Tusker Medical devices

FDA 510(k) Submission Details - K171239

510(k) Number K171239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2017
Decision Date June 28, 2017
Days to Decision 62 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 89d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

ETD Device Classification - Class 2, Special Controls

Product Code ETD Tube, Tympanostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3880
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETD Tube, Tympanostomy

All 69
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K171239.
Tympanostomy Tubes
K232059 · Grace Medical, Inc. · Nov 2023
Hummingbird Tympanostomy Tube System
K221254 · Preceptis Medical, Inc. · Jul 2022
Hummingbird Tympanostomy Tube System
K200952 · Preceptis Medical, Inc. · Jun 2020
Ventilation (Tympanostomy) Tubes
K151067 · Medtronic Xomed, Inc. · Jul 2015
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
K103595 · Acclarent, Inc. · Apr 2011
TYMPANOSTOMY TUBE
K082188 · Acclarent, Inc. · Sep 2008