5.0 MM IRRIGATION/ASPIRATION PROBE— 510(k) K931856

Substantially Equivalent

Mayaguez Medical Center

FDA 510(k) clearance K931856 for 5.0 MM IRRIGATION/ASPIRATION PROBE, Substantially Equivalent on 1993-08-10. Applicant: Mayaguez Medical Center.

Clearance details

Applicant: Mayaguez Medical Center
Product code: Code GCY
Advisory panel: General, Plastic Surgery
Date received: 1993-04-13
Decision date: 1993-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Trophy Club, TX, US

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Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.