AO FLEXIBLE LARYNGOSCOPE, #LS-7— 510(k) K802331

Name: FDA 510(k) clearance K802331
Creator: U.S. Food and Drug Administration
Published: 1980-10-10

Substantially Equivalent

American Optical Corp.

FDA 510(k) clearance K802331 for AO FLEXIBLE LARYNGOSCOPE, #LS-7, Substantially Equivalent on 1980-10-10. Applicant: American Optical Corp.. Device class: 1.

Clearance details

Applicant: American Optical Corp.
Product code: Code CAL
Device class: Class 1
Regulation: 21 CFR 868.5530
Advisory panel: Anesthesiology
Date received: 1980-09-23
Decision date: 1980-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K951195 — FI-10P1995-04-06
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K852994 — REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-111985-07-29
K850978 — OLYMPUS LF-1 INTUBATION SCOPE1985-05-23

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K931354 — P4000 PHACOEMULSIFIER1994-02-22
K931358 — AORP4000 REUSABLE PAK1994-02-22
K931357 — AOD4000 DISPOSABLE PAK1994-01-25

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.