SALUTE— 510(k) K003522

Substantially Equivalent

Onux Medical, Inc.

FDA 510(k) clearance K003522 for SALUTE, Substantially Equivalent on 2001-02-13. Applicant: Onux Medical, Inc..

Clearance details

Applicant: Onux Medical, Inc.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2000-11-15
Decision date: 2001-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hampton, NH, 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.