INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT— 510(k) K091215

Substantially Equivalent

Power Medical Interventions, Inc.

FDA 510(k) clearance K091215 for INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT, Substantially Equivalent on 2009-05-18. Applicant: Power Medical Interventions, Inc..

Clearance details

Applicant: Power Medical Interventions, Inc.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2009-04-27
Decision date: 2009-05-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Langhorne, PA, 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.