Cleared Traditional

STRAITH ORAL AIRWAY

K831078 · Surgical Technology Laboratories, Inc. · Anesthesiology
Jun 1983
Decision
81d
Days
Class 1
Risk

About This 510(k) Submission

K831078 is an FDA 510(k) clearance for the STRAITH ORAL AIRWAY, a Airway, Oropharyngeal, Anesthesiology (Class I — General Controls, product code CAE), submitted by Surgical Technology Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1983, 81 days after receiving the submission on April 4, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5110.

Submission Details

510(k) Number K831078 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 1983
Decision Date June 24, 1983
Days to Decision 81 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAE — Airway, Oropharyngeal, Anesthesiology
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5110

Similar Devices — CAE Airway, Oropharyngeal, Anesthesiology

All 56
LMA FAMILY OF AIRWAYS
K130304 · The Laryngeal Mask Co., Ltd. · May 2014
KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
K033189 · King Systems Corp. · May 2004
KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
K033186 · King Systems Corp. · Apr 2004
KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
K021634 · King Systems Corp. · Jan 2003
CUFFED OROPHARYNGEAL AIRWAY (COPA)
K955721 · Mallinckrodt Medical · Mar 1997
RUSCH OPTOSAFE
K960240 · Rusch Intl. · Apr 1996