DISPOSABLE SUCTION PROBE— 510(k) K942061

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K942061 for DISPOSABLE SUCTION PROBE, Substantially Equivalent on 1994-05-16. Applicant: United States Surgical, A Division of Tyco Healthc.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1994-04-29
Decision date: 1994-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

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Adverse events under product code JOL

product code JOL

Death: 7
Injury: 177
Malfunction: 1,306
Other: 1
Total: 1,491

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.