MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET— 510(k) K003417

Substantially Equivalent

Richard Wolf Medical Instruments Corp.

FDA 510(k) clearance K003417 for MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET, Substantially Equivalent on 2001-04-04. Applicant: Richard Wolf Medical Instruments Corp..

Clearance details

Applicant: Richard Wolf Medical Instruments Corp.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2000-11-02
Decision date: 2001-04-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Vernon Hills, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.