VCI SUCTION/IRRIGATION TUBING SET— 510(k) K934382

Substantially Equivalent

Vital Concepts, Inc.

FDA 510(k) clearance K934382 for VCI SUCTION/IRRIGATION TUBING SET, Substantially Equivalent on 1994-02-01. Applicant: Vital Concepts, Inc..

Clearance details

Applicant: Vital Concepts, Inc.
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1993-09-09
Decision date: 1994-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, 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.