ONCOBIONIC SYSTEM
FDA 510(k) clearance K080376 · decided 2008-04-02
Clearance details
- K-number
- K080376
- Device name
- ONCOBIONIC SYSTEM
- Applicant
- Oncobionic Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2008-02-12
- Decision date
- 2008-04-02
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- OAB
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Rancho Santa Margarita, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603 Queens recall (Z-3258-2011) | Angiodynamics, Inc. | 2011-09-23 |