3 IN 1 AUTOMATIC TOURNIQUET— 510(k) K880020

Substantially Equivalent

Systematics Mfg. & Tool Co., Inc.

FDA 510(k) clearance K880020 for 3 IN 1 AUTOMATIC TOURNIQUET, Substantially Equivalent on 1988-03-17. Applicant: Systematics Mfg. & Tool Co., Inc..

Clearance details

Applicant: Systematics Mfg. & Tool Co., Inc.
Product code: Code KCY
Advisory panel: General, Plastic Surgery
Date received: 1988-01-05
Decision date: 1988-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bohemia, NY, US

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Adverse events under product code KCY

product code KCY

Malfunction: 868
Total: 868

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.