NT 2000 LESIONING GENERATOR
FDA 510(k) clearance K111576 · decided 2011-09-20
Clearance details
- K-number
- K111576
- Device name
- NT 2000 LESIONING GENERATOR
- Applicant
- Neuro Therm, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-06
- Decision date
- 2011-09-20
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- GXD
- Device class
- 2
- Regulation number
- 882.4400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Ashland, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator recall (Z-0209-2024) | Abbott | 2023-11-02 |
| Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX recall (Z-1361-2016) | Neurotherm, Inc. | 2016-04-09 |