LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)— 510(k) K981334

Substantially Equivalent

Richard Wolf Medical Instruments Corp.

FDA 510(k) clearance K981334 for LAPARO CO2-PNEU (AND WITH VIDEO MONITORING), Substantially Equivalent on 1998-09-10. Applicant: Richard Wolf Medical Instruments Corp..

Clearance details

Applicant: Richard Wolf Medical Instruments Corp.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 1998-04-13
Decision date: 1998-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

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Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.