HYSTERO CO2-PNEU 2221— 510(k) K964136

Substantially Equivalent

Richard Wolf Medical Instruments Corp.

FDA 510(k) clearance K964136 for HYSTERO CO2-PNEU 2221, Substantially Equivalent on 1997-01-10. Applicant: Richard Wolf Medical Instruments Corp..

Clearance details

Applicant: Richard Wolf Medical Instruments Corp.
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 1996-10-15
Decision date: 1997-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

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Adverse events under product code HIG

product code HIG

Death: 8
Other: 2
Total: 10

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.