510(k) K000673— HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241

Substantially Equivalent

Richard Wolf Medical Instruments Corp.

Clearance details

Applicant: Richard Wolf Medical Instruments Corp.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2000-02-28
Decision date: 2000-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.