Cleared Traditional

TYMPANOSTOMY TUBE

K981575 · Grace Medical, Inc. · Ear, Nose, Throat
Jul 1998
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K981575 is an FDA 510(k) clearance for the TYMPANOSTOMY TUBE, a Tube, Tympanostomy (Class II — Special Controls, product code ETD), submitted by Grace Medical, Inc. (Bartlett, US). The FDA issued a Cleared decision on July 15, 1998, 72 days after receiving the submission on May 4, 1998. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3880.

Submission Details

510(k) Number K981575 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1998
Decision Date July 15, 1998
Days to Decision 72 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

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

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