S3 MEDICATED GAUZE— 510(k) K874219

Substantially Equivalent

Surgical Specialties, Inc.

FDA 510(k) clearance K874219 for S3 MEDICATED GAUZE, Substantially Equivalent on 1987-11-23. Applicant: Surgical Specialties, Inc..

Clearance details

Applicant: Surgical Specialties, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1987-10-16
Decision date: 1987-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Readding, PA, US

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Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.