Cleared Special

TULA Tube Delivery System

K171239 · Tusker Medical · Ear, Nose, Throat

Jun 2017

Decision

62d

Days

Class 2

Risk

About This 510(k) Submission

K171239 is an FDA 510(k) clearance for the TULA Tube Delivery System, a Tube, Tympanostomy (Class II — Special Controls, product code ETD), submitted by Tusker Medical (Menlo Park, US). The FDA issued a Cleared decision on June 28, 2017, 62 days after receiving the submission on April 27, 2017. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3880.

Submission Details

510(k) Number	K171239 FDA.gov
FDA Decision	Cleared 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