I45, I45S, I60, AND I60S— 510(k) K071708

Substantially Equivalent

Power Medical Interventions, Inc.

FDA 510(k) clearance K071708 for I45, I45S, I60, AND I60S, Substantially Equivalent on 2007-09-27. Applicant: Power Medical Interventions, Inc..

Clearance details

Applicant: Power Medical Interventions, Inc.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2007-06-21
Decision date: 2007-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
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.