NT 2000 LESIONING GENERATOR— 510(k) K111576
Substantially EquivalentNeuro Therm, Inc.
FDA 510(k) clearance K111576 for NT 2000 LESIONING GENERATOR, Substantially Equivalent on 2011-09-20. Applicant: Neuro Therm, Inc.. Device class: 2.
Clearance details
- Applicant
- Neuro Therm, Inc.
- Product code
- Code GXD
- Device class
- Class 2
- Regulation
- 21 CFR 882.4400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ashland, MA, US
Recent devices under product code GXD
view allMore clearances from Neuro Therm, Inc.
view allAdverse events under product code GXD
product code GXD- Injury
- 228
- Total
- 228
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K111576
K-number listed on FDA's recall record- Z-0209-2024 — Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
- Z-1549-2021 — NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
- Z-0664-2020 — Radiofrequency Grounding Pad, REF RF-DGP-L
- Z-1361-2016 — Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111576.
Data sourced from openFDA. This site is unofficial and independent of the FDA.