DIRECT PERORAL CHOLANGIOSCOPY BALLOON— 510(k) K101095

Substantially Equivalent

Wilson-Cook Medical, Inc.

FDA 510(k) clearance K101095 for DIRECT PERORAL CHOLANGIOSCOPY BALLOON, Substantially Equivalent on 2010-07-19. Applicant: Wilson-Cook Medical, Inc..

Clearance details

Applicant: Wilson-Cook Medical, Inc.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2010-04-20
Decision date: 2010-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston Salem, NC, 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.