SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN— 510(k) K926496

Substantially Equivalent

Sil-Med Corp.

FDA 510(k) clearance K926496 for SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN, Substantially Equivalent on 1995-05-24. Applicant: Sil-Med Corp..

Clearance details

Applicant: Sil-Med Corp.
Product code: Code GBX
Advisory panel: General, Plastic Surgery
Date received: 1992-12-29
Decision date: 1995-05-24
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.