Cleared Traditional

K963727 - HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER (FDA 510(k) Clearance)

K963727 · Medtronic Xomed · Ear, Nose, Throat device
Feb 1997
Decision
148d
Days
Class 2
Risk

K963727 is an FDA 510(k) clearance for the HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER. This device is classified as a Tube, Tympanostomy (Class II - Special Controls, product code ETD).

Submitted by Medtronic Xomed (Jacksonville, US). The FDA issued a Cleared decision on February 11, 1997, 148 days after receiving the submission on September 16, 1996.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.

Submission Details

510(k) Number K963727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date February 11, 1997
Days to Decision 148 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