K926495

Substantially Equivalent

SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE

Applicant: Sil-Med Corp.
Product code: GBX
Advisory panel: General, Plastic Surgery
Date received: 1992-12-29
Decision date: 1994-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taunton, MA, US

Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.