SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR— 510(k) K961295

Substantially Equivalent

Sil-Med Corp.

FDA 510(k) clearance K961295 for SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR, Substantially Equivalent on 1996-06-26. Applicant: Sil-Med Corp..

Clearance details

Applicant: Sil-Med Corp.
Product code: Code GBX
Advisory panel: General, Plastic Surgery
Date received: 1996-04-04
Decision date: 1996-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taunton, MA, US

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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.