OPTUS LARYNGOSCOPES— 510(k) K945269

Name: FDA 510(k) clearance K945269
Creator: U.S. Food and Drug Administration
Published: 1994-11-07

Substantially Equivalent

Optus, Inc.

FDA 510(k) clearance K945269 for OPTUS LARYNGOSCOPES, Substantially Equivalent on 1994-11-07. Applicant: Optus, Inc.. Device class: 1.

Clearance details

Applicant: Optus, Inc.
Product code: Code CCW
Device class: Class 1
Regulation: 21 CFR 868.5540
Advisory panel: Anesthesiology
Date received: 1994-10-28
Decision date: 1994-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CCW

view all

K191602 — APA Oxy Blade2019-08-02
K163412 — Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)2017-06-22
K140951 — YEESCOPE LARYNGOSCOPES2014-11-10
K121378 — AIRTRAQ SP AIRTRAQ AVANT2012-06-21
K063477 — NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET2007-02-09

More clearances from Optus, Inc.

view all

K945264 — OPTUS OTOSCOPES1996-02-02
K953913 — OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES1996-01-22
K945268 — OPTUS BRONCHOSCOPES1995-12-21
K945265 — OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES1995-09-12
K945262 — OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES1995-05-26

Adverse events under product code CCW

product code CCW

Death: 31
Injury: 136
Malfunction: 3,703
Other: 1
Total: 3,871

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.