ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT
FDA 510(k) clearance K080202 · decided 2008-05-08
Clearance details
- K-number
- K080202
- Device name
- ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT
- Applicant
- Oncobionics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-01-28
- Decision date
- 2008-05-08
- Days to decision
- 101 days
- Clearance type
- Special
- 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 |
|---|---|---|
| NanoKnife Irreversible Electroporation System. System consists of multiple components: Gen recall (Z-0918-2012) | Angiodynamics Worldwide Headquarters | 2012-01-27 |