GAUZE SPONGE— 510(k) K853742

Substantially Equivalent

South Mountain Medical

FDA 510(k) clearance K853742 for GAUZE SPONGE, Substantially Equivalent on 1985-10-08. Applicant: South Mountain Medical.

Clearance details

Applicant: South Mountain Medical
Product code: Code GDY
Advisory panel: General, Plastic Surgery
Date received: 1985-09-06
Decision date: 1985-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Asheville, NC, 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.