ELECTRONIC INSUFFLATOR, MODEL NO. 2054.60— 510(k) K882185

Substantially Equivalent

Richard Wolf Medical Instruments Corp.

FDA 510(k) clearance K882185 for ELECTRONIC INSUFFLATOR, MODEL NO. 2054.60, Substantially Equivalent on 1988-06-22. Applicant: Richard Wolf Medical Instruments Corp..

Clearance details

Applicant: Richard Wolf Medical Instruments Corp.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 1988-05-24
Decision date: 1988-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosemont, 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.