WILTEK STANDARD CHOLANGIOGRAPHY CATHETER— 510(k) K912288

Substantially Equivalent

Wiltek Medical, Inc.

FDA 510(k) clearance K912288 for WILTEK STANDARD CHOLANGIOGRAPHY CATHETER, Substantially Equivalent on 1991-09-23. Applicant: Wiltek Medical, Inc..

Clearance details

Applicant: Wiltek Medical, Inc.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 1991-05-23
Decision date: 1991-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, US

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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.