LARYNGESCOPE— 510(k) K831981

Name: FDA 510(k) clearance K831981
Creator: U.S. Food and Drug Administration
Published: 1983-09-29

Substantially Equivalent

W.E. Leder Enterprises, Inc.

FDA 510(k) clearance K831981 for LARYNGESCOPE, Substantially Equivalent on 1983-09-29. Applicant: W.E. Leder Enterprises, Inc.. Device class: 1.

Clearance details

Applicant: W.E. Leder Enterprises, Inc.
Product code: Code CCW
Device class: Class 1
Regulation: 21 CFR 868.5540
Advisory panel: Anesthesiology
Date received: 1983-06-20
Decision date: 1983-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from W.E. Leder Enterprises, Inc.

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K831877 — ARF 850 E1983-11-03
K831878 — CARDIO-SCOPE MINI MONITOR1983-09-29
K830159 — ANESTHESIA APPARATUS PH-351983-03-09
K830160 — ANESTHESIA APPARATUS #FO 20S1983-03-09
K830161 — ANESTHESIA APATATUS #D-251983-03-09

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.