AMERICAN EDWARDS LABORATORIES FLEXISCOPE— 510(k) K852759

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K852759 for AMERICAN EDWARDS LABORATORIES FLEXISCOPE, Substantially Equivalent on 1985-08-22. Applicant: American Edwards Laboratories.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1985-06-28
Decision date: 1985-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.