MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY— 510(k) K041995

Substantially Equivalent

Uresil, LLC

FDA 510(k) clearance K041995 for MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY, Substantially Equivalent on 2004-08-19. Applicant: Uresil, LLC.

Clearance details

Applicant: Uresil, LLC
Product code: Code GBO
Advisory panel: General, Plastic Surgery
Date received: 2004-07-23
Decision date: 2004-08-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Skokie, IL, US

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Adverse events under product code GBO

product code GBO

Death: 8
Injury: 236
Total: 244

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.