ONCOBIONIC SYSTEM— 510(k) K060054

Substantially Equivalent

Oncobionics, Inc.

FDA 510(k) clearance K060054 for ONCOBIONIC SYSTEM, Substantially Equivalent on 2006-11-21. Applicant: Oncobionics, Inc..

Clearance details

Applicant: Oncobionics, Inc.
Product code: Code OAB
Advisory panel: General, Plastic Surgery
Date received: 2006-01-06
Decision date: 2006-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code OAB

product code OAB

Death: 5
Total: 5

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.