Cleared Traditional

K232702 - Solo+ Tympanostomy Tube Device (TTD)
(FDA 510(k) Clearance)

K232702 · Aventamed Dac · Ear, Nose, Throat

May 2024

Decision

258d

Days

Class 2

Risk

K232702 is an FDA 510(k) clearance for the Solo+ Tympanostomy Tube Device (TTD), a Tube, Tympanostomy (Class II — Special Controls, product code ETD), submitted by Aventamed Dac (Bishopstown, IE). The FDA issued a Cleared decision on May 20, 2024, 258 days after receiving the submission on September 5, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3880.

Submission Details

510(k) Number	K232702 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 05, 2023
Decision Date	May 20, 2024
Days to Decision	258 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF