KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST.— 510(k) K860956

Substantially Equivalent

Medical Corp. of America

FDA 510(k) clearance K860956 for KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST., Substantially Equivalent on 1986-06-02. Applicant: Medical Corp. of America.

Clearance details

Applicant: Medical Corp. of America
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1986-03-13
Decision date: 1986-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westminister, CA, US

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Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

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.