NEUSTEIN LARYNGOSCOPE— 510(k) K901164

Name: FDA 510(k) clearance K901164
Creator: U.S. Food and Drug Administration
Published: 1990-10-09

Substantially Equivalent

Neutech Corp.

FDA 510(k) clearance K901164 for NEUSTEIN LARYNGOSCOPE, Substantially Equivalent on 1990-10-09. Applicant: Neutech Corp.. Device class: 1.

Clearance details

Applicant: Neutech Corp.
Product code: Code CCW
Device class: Class 1
Regulation: 21 CFR 868.5540
Advisory panel: Anesthesiology
Date received: 1990-03-12
Decision date: 1990-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, NJ, US

Download summary PDF View on FDA.gov ↗

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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.