Cleared Traditional

K894032 - EVAC-TUBE
(FDA 510(k) Clearance)

K894032 · Sharn, Inc. · Anesthesiology
Aug 1989
Decision
86d
Days
Class 2
Risk

K894032 is an FDA 510(k) clearance for the EVAC-TUBE. This device is classified as a Airway, Esophageal (obturator) (Class II — Special Controls, product code CAO).

Submitted by Sharn, Inc. (Tampa, US). The FDA issued a Cleared decision on August 31, 1989, 86 days after receiving the submission on June 6, 1989.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5650.

Submission Details

510(k) Number K894032 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 1989
Decision Date August 31, 1989
Days to Decision 86 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAO — Airway, Esophageal (obturator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5650