SIMPEX INC. SURGICAL DRESSING— 510(k) K913794

Substantially Equivalent

Simpex, Inc.

FDA 510(k) clearance K913794 for SIMPEX INC. SURGICAL DRESSING, Substantially Equivalent on 1991-11-20. Applicant: Simpex, Inc..

Clearance details

Applicant: Simpex, Inc.
Product code: Code GDY
Advisory panel: General, Plastic Surgery
Date received: 1991-08-23
Decision date: 1991-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jenkintown, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GDY

product code GDY

Malfunction: 764
Total: 764

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.