Cleared Traditional

PILOT TUBE REPAIR KIT

K973755 · Instrumentation Industries, Inc. · Anesthesiology
Dec 1997
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K973755 is an FDA 510(k) clearance for the PILOT TUBE REPAIR KIT, a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on December 17, 1997, 76 days after receiving the submission on October 2, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K973755 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 1997
Decision Date December 17, 1997
Days to Decision 76 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BSK — Cuff, Tracheal Tube, Inflatable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5750