NanoKnife System
FDA 510(k) clearance K183385 · decided 2019-06-18
Clearance details
- K-number
- K183385
- Device name
- NanoKnife System
- Applicant
- Angiodynamics
- Decision
- Substantially Equivalent
- Date received
- 2018-12-06
- Decision date
- 2019-06-18
- Days to decision
- 194 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
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Angiodynamics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation o recall (Z-1381-2023) | Angiodynamics, Inc. | 2023-04-12 |