ONCOBIONIC SYSTEM— 510(k) K080376
Substantially EquivalentOncobionic Incorporated
FDA 510(k) clearance K080376 for ONCOBIONIC SYSTEM, Substantially Equivalent on 2008-04-02. Applicant: Oncobionic Incorporated. Device class: 2.
Clearance details
- Applicant
- Oncobionic Incorporated
- Product code
- Code OAB
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rancho Santa Margarita, CA, US
Recent devices under product code OAB
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- K253826 — Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle
- K253198 — NanoKnife Generator (H78720300351US0)
- K242687 — NanoKnife Generator (H78720300301US0) +3 more
- K240376 — Electroporation System (N3000)
Adverse events under product code OAB
product code OAB- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . 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.