ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT— 510(k) K080202

Substantially Equivalent

Oncobionics, Inc.

FDA 510(k) clearance K080202 for ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT, Substantially Equivalent on 2008-05-08. Applicant: Oncobionics, Inc..

Clearance details

Applicant: Oncobionics, Inc.
Product code: Code OAB
Advisory panel: General, Plastic Surgery
Date received: 2008-01-28
Decision date: 2008-05-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Rancho Santa Margarita, CA, 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.