510(k) Report

FDA applicant

Oncobionic Incorporated

Rancho Santa Margarita, CA1 decision2008–20081 recall

FDA records 1 decision for Oncobionic Incorporated (Rancho Santa Margarita, CA) in 2008: 1 510(k) clearance. All are in product code OAB (Low Energy Direct Current Thermal Ablation…). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Oncobionic Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2008high 1 (2011) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Oncobionic Incorporated by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OABLow Energy Direct Current Thermal Ablation System1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K080376Oncobionic SystemOncobionic Incorporated · 20081cites it

What has FDA decided for it lately?

  • K080376Oncobionic SystemOncobionic Incorporated · 20081 recall

The one decision as Oncobionic Incorporated →

What has been recalled?

1 recall linked to its devices; the latest:

  • K080376ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603…Apr 4, 2011