ULTRACLIP II WING AND ULTRACLIP II COIL— 510(k) K063238

Substantially Equivalent

Inrad

FDA 510(k) clearance K063238 for ULTRACLIP II WING AND ULTRACLIP II COIL, Substantially Equivalent on 2007-01-30. Applicant: Inrad.

Clearance details

Applicant: Inrad
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2006-10-26
Decision date: 2007-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kentwood, MI, US

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Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.