MODEL 2231 CO2 INSUFFLATOR— 510(k) K934884

Substantially Equivalent

Richard Wolf Medical Instruments Corp.

FDA 510(k) clearance K934884 for MODEL 2231 CO2 INSUFFLATOR, Substantially Equivalent on 1995-02-07. Applicant: Richard Wolf Medical Instruments Corp..

Clearance details

Applicant: Richard Wolf Medical Instruments Corp.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 1993-10-12
Decision date: 1995-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

Download summary PDF View on FDA.gov ↗

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.