Cleared Traditional

Biowy Tym Tube (TT)

K233658 · Biowy Corporation · Ear, Nose, Throat
Feb 2024
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K233658 is an FDA 510(k) clearance for the Biowy Tym Tube (TT), a Tube, Tympanostomy (Class II — Special Controls, product code ETD), submitted by Biowy Corporation (Lake Forest, US). The FDA issued a Cleared decision on February 16, 2024, 93 days after receiving the submission on November 15, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3880.

Submission Details

510(k) Number K233658 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2023
Decision Date February 16, 2024
Days to Decision 93 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETD — Tube, Tympanostomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3880

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