Cleared Traditional

SHILEY SPECIALIZED TRACHEOSTOMY TUBE

K890194 · Shiley, Inc. · Anesthesiology
Jul 1989
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K890194 is an FDA 510(k) clearance for the SHILEY SPECIALIZED TRACHEOSTOMY TUBE, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on July 20, 1989, 184 days after receiving the submission on January 17, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K890194 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 1989
Decision Date July 20, 1989
Days to Decision 184 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code JOH — Tube Tracheostomy And Tube Cuff
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

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