510(k) K111576 ยท GXD Generator, Lesion, Radiofrequency
NT 2000 LESIONING GENERATOR
| Applicant | Neuro Therm, Inc., Ashland MA, US |
| Decision | Substantially Equivalent, Sep 20, 2011 |
| Received | Jun 6, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111576
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2023 | Abbott Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator Open, Classified |
GXD | None listed |
| Apr 22, 2021 | Abbott Laboratories Inc. (St Jude Medical) NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000 Terminated |
GXD | None listed |
| Oct 14, 2019 | Abbott Medical Radiofrequency Grounding Pad, REF RF-DGP-L Terminated |
GXD | None listed |
| Apr 9, 2016 | Neurotherm, Inc. Neurotherm NT2000iX RF Generator
Model Number: RFG-NT -2000iX Terminated |
GXD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.