PI-PNEUMO INTESTINAL STAPLING CARTRIDGE— 510(k) K851122

Substantially Equivalent

Surgeons Choice, Inc.

FDA 510(k) clearance K851122 for PI-PNEUMO INTESTINAL STAPLING CARTRIDGE, Substantially Equivalent on 1985-04-25. Applicant: Surgeons Choice, Inc..

Clearance details

Applicant: Surgeons Choice, Inc.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 1985-03-19
Decision date: 1985-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.