LIXISCOPE - OR LIXI— 510(k) K820658

Name: FDA 510(k) clearance K820658
Creator: U.S. Food and Drug Administration
Published: 1982-05-18

Substantially Equivalent

Lixi, Inc.

FDA 510(k) clearance K820658 for LIXISCOPE - OR LIXI, Substantially Equivalent on 1982-05-18. Applicant: Lixi, Inc.. Device class: 2.

Clearance details

Applicant: Lixi, Inc.
Product code: Code OXO
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1982-03-10
Decision date: 1982-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

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.