STERILE X-RAY DETECTABLE GAUZE SPONGES— 510(k) K941522

Substantially Equivalent

Cush Medical Products

FDA 510(k) clearance K941522 for STERILE X-RAY DETECTABLE GAUZE SPONGES, Substantially Equivalent on 1994-05-12. Applicant: Cush Medical Products.

Clearance details

Applicant: Cush Medical Products
Product code: Code GDY
Advisory panel: General, Plastic Surgery
Date received: 1994-03-30
Decision date: 1994-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piney Flats, TN, US

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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.