Cleared Traditional

Tympanostomy Tubes

K232059 · Grace Medical, Inc. · Ear, Nose, Throat
Nov 2023
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K232059 is an FDA 510(k) clearance for the Tympanostomy Tubes, a Tube, Tympanostomy (Class II — Special Controls, product code ETD), submitted by Grace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on November 24, 2023, 136 days after receiving the submission on July 11, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3880.

Submission Details

510(k) Number K232059 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2023
Decision Date November 24, 2023
Days to Decision 136 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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