510(k) K080202
- Device
- ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT
- Applicant
- ONCOBIONICS, INC.
- 510(k) number
- K080202
- Product code
- OAB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-05-08
- Date received
- 2008-01-28
- Regulation
- 878.4400
- Classification name
- Low Energy Direct Current Thermal Ablation System
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL MIKUS
- Address
- 30211 Avenida De Las Banderas Suite 200 Rancho Santa Margarita CA US 92679 92679
FDA Registration Numbers#
- 3043527620
- 2244478
- 1721676
- 9611854
- 1319639
- 3016020790
- 3004986960
- 3021023752
- 1319211
- 3017448139
- 1000523114
- 3008849319
- 3017892510
- 3015540957
- 3017185164
- 2031093
Source Documents#
Other 510(k) Records For Product Code OAB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253826 | Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle | Galvanize Therapeutics, Inc. | 2026-05-07 |
| K253198 | NanoKnife Generator (H78720300351US0) | Angiodynamics | 2026-03-24 |
| K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) | AngioDynamics, Inc. | 2024-12-06 |
| K240376 | Electroporation System (N3000) | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2024-10-04 |
| K233884 | INUMI™ Flex Needle | Galvanize Therapeutics, Inc. | 2024-05-22 |
| K240297 | Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) | Us Medical Innovations, LLC | 2024-05-03 |
| K222001 | Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe | Zhejiang Curaway Medical Technology Co., Ltd. | 2023-06-08 |
| K212871 | Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode | Galvanize Therapeutics, Inc. | 2022-06-17 |
| K183385 | NanoKnife System | Angiodynamics | 2019-06-18 |
| K150089 | NanoKnife System | AngioDynamics, Inc. | 2015-06-18 |
| K102329 | NANOKNIFE SYSTEM | AngioDynamics, Inc. | 2011-10-24 |
| K080376 | ONCOBIONIC SYSTEM | Oncobionic Incorporated | 2008-04-02 |
| K060054 | ONCOBIONIC SYSTEM | Oncobionics, Inc. | 2006-11-21 |
Legacy Summary#
summary
FDA Review#
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