ENDOSCOPIC VIDEOSYSTEM— 510(k) K822959

Name: FDA 510(k) clearance K822959
Creator: U.S. Food and Drug Administration
Published: 1982-10-22

Substantially Equivalent

Eder Instrument Co, Inc.

FDA 510(k) clearance K822959 for ENDOSCOPIC VIDEOSYSTEM, Substantially Equivalent on 1982-10-22. Applicant: Eder Instrument Co, Inc.. Device class: 2.

Clearance details

Applicant: Eder Instrument Co, Inc.
Product code: Code FET
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1982-10-05
Decision date: 1982-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, Wi 53202, US

Download summary PDF View on FDA.gov ↗

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K843498 — BIPOLAR SUCTION ELECTRODE1984-12-14
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K843499 — ARTHROSCOPY LEG HOLDER1984-10-31
K831255 — LARYNGOSCOPE ATTACHMENT PH20001983-09-12
K831240 — LASER BRONCHOSCOPE1983-07-26

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.