ULTRACLIP II MR— 510(k) K041201

Substantially Equivalent

Inrad

FDA 510(k) clearance K041201 for ULTRACLIP II MR, Substantially Equivalent on 2004-06-03. Applicant: Inrad.

Clearance details

Applicant: Inrad
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2004-05-07
Decision date: 2004-06-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Kentwood, MI, 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.