TOURNIQUET CUFF; PNEUMATIC TOURNIQUET— 510(k) K012632

Substantially Equivalent

Medical Instruments Technology, Inc.

FDA 510(k) clearance K012632 for TOURNIQUET CUFF; PNEUMATIC TOURNIQUET, Substantially Equivalent on 2001-10-26. Applicant: Medical Instruments Technology, Inc..

Clearance details

Applicant: Medical Instruments Technology, Inc.
Product code: Code KCY
Advisory panel: General, Plastic Surgery
Date received: 2001-08-13
Decision date: 2001-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. George, UT, 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.