OPRATEX ABDOMINAL PAD— 510(k) K802798

Substantially Equivalent

Secol Co.

FDA 510(k) clearance K802798 for OPRATEX ABDOMINAL PAD, Substantially Equivalent on 1980-12-11. Applicant: Secol Co..

Clearance details

Applicant: Secol Co.
Product code: Code GDY
Advisory panel: General, Plastic Surgery
Date received: 1980-11-04
Decision date: 1980-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.