VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726— 510(k) K002650

Substantially Equivalent

Bentec Medical, Inc.

FDA 510(k) clearance K002650 for VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726, Substantially Equivalent on 2001-02-16. Applicant: Bentec Medical, Inc..

Clearance details

Applicant: Bentec Medical, Inc.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2000-08-25
Decision date: 2001-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodland, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.