K002328

Substantially Equivalent

SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR

Applicant: Richard Wolf Medical Instruments Corp.
Product code: HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2000-08-01
Decision date: 2001-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

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.