BRIMFIELD SCIEN. INSTRU. DISPOS. STERILE SURG. BLA— 510(k) K851880

Substantially Equivalent

J-Pac, LLC

FDA 510(k) clearance K851880 for BRIMFIELD SCIEN. INSTRU. DISPOS. STERILE SURG. BLA, Substantially Equivalent on 1985-05-21. Applicant: J-Pac, LLC.

Clearance details

Applicant: J-Pac, LLC
Product code: Code GFA
Advisory panel: General, Plastic Surgery
Date received: 1985-04-29
Decision date: 1985-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, NH, US

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Adverse events under product code GFA

product code GFA

Death: 2
Injury: 140
Malfunction: 2,337
Total: 2,479

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.