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

Name: FDA 510(k) clearance K931856
Creator: U.S. Food and Drug Administration
Published: 1993-08-10

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. Device class: 1.

Clearance details

Applicant: Mayaguez Medical Center
Product code: Code GCY
Device class: Class 1
Regulation: 21 CFR 878.4680
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

Download summary PDF View on FDA.gov ↗

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K950754 — MACRO SUCTION TUBE MODEL NO 100611995-04-25

More clearances from Mayaguez Medical Center

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K932804 — IRRIGATING TAPERED PROBE1993-08-16
K932805 — 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT1993-08-16
K931950 — POOLE TIP SUCTION PROBE1993-08-11
K932806 — POOLE TIP SUCTION PROBE & TUBING KIT1993-08-11
K931854 — ENDOSCOPIC BLUNT DISSECTING INSTRUMENT1993-08-10

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.