SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)— 510(k) K032701

Substantially Equivalent

Power Medical Interventions, Inc.

FDA 510(k) clearance K032701 for SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33), Substantially Equivalent on 2003-09-30. Applicant: Power Medical Interventions, Inc..

Clearance details

Applicant: Power Medical Interventions, Inc.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2003-09-02
Decision date: 2003-09-30
Decision: Substantially Equivalent
Clearance type: Special
Location: New Hope, PA, US

Download summary PDF View on FDA.gov ↗

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.