GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C— 510(k) K021632

Substantially Equivalent

Uresil, L.P.

FDA 510(k) clearance K021632 for GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C, Substantially Equivalent on 2002-06-13. Applicant: Uresil, L.P..

Clearance details

Applicant: Uresil, L.P.
Product code: Code GBO
Advisory panel: General, Plastic Surgery
Date received: 2002-05-17
Decision date: 2002-06-13
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.