EFFNER-SALING LARYNGOSCOPE FOR NEW-BORN— 510(k) K844776

Name: FDA 510(k) clearance K844776
Creator: U.S. Food and Drug Administration
Published: 1985-10-01

Substantially Equivalent

Medical Instruments and Lamps

FDA 510(k) clearance K844776 for EFFNER-SALING LARYNGOSCOPE FOR NEW-BORN, Substantially Equivalent on 1985-10-01. Applicant: Medical Instruments and Lamps. Device class: 1.

Clearance details

Applicant: Medical Instruments and Lamps
Product code: Code CCW
Device class: Class 1
Regulation: 21 CFR 868.5540
Advisory panel: Anesthesiology
Date received: 1984-12-10
Decision date: 1985-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Washington, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CCW

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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

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.