OLYMPUS LF-1 INTUBATION SCOPE— 510(k) K850978

Name: FDA 510(k) clearance K850978
Creator: U.S. Food and Drug Administration
Published: 1985-05-23

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K850978 for OLYMPUS LF-1 INTUBATION SCOPE, Substantially Equivalent on 1985-05-23. Applicant: Olympus Corp.. Device class: 1.

Clearance details

Applicant: Olympus Corp.
Product code: Code CAL
Device class: Class 1
Regulation: 21 CFR 868.5530
Advisory panel: Anesthesiology
Date received: 1985-03-08
Decision date: 1985-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

Download summary PDF View on FDA.gov ↗

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K852994 — REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-111985-07-29
K802331 — AO FLEXIBLE LARYNGOSCOPE, #LS-71980-10-10

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K931763 — HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS1994-08-29
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Adverse events under product code CAL

product code CAL

Malfunction: 885
Total: 885

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.