Company ยท US
Neuronetics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2024. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
2recalls (1 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 22, 2024 | K231926 | NeuroStar Advanced Therapy System (All previously cleared models) Neuronetics, Inc. | OBP |
| Dec 13, 2023 | K233621 | NeuroStar Advanced Therapy System (Version 3.8) Neuronetics | OBP |
| Jun 8, 2023 | K231350 | OCD MT Cap (85-00397-000) Neuronetics | QCI |
| Apr 4, 2023 | K230029 | NeuroStar Advanced Therapy System (Version 3.7) Neuronetics | OBP |
| Aug 24, 2022 | K222230 | NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Neuronetics, Inc. | OBP |
| Jul 15, 2022 | K220127 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health Neuronetics, Inc. | OBP |
| May 6, 2022 | K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy Sys Neuronetics, Inc. | QCI |
| Dec 10, 2021 | K213543 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health Neuronetics, Inc. | OBP |
| Nov 20, 2020 | K201158 | NeuroStar Advanced Therapy Neuronetics, Inc. | OBP |
| Sep 11, 2016 | K161519 | NeuroStar TMS Therapy System Neuronetics, Inc. | OBP |
| Jun 10, 2016 | K160703 | NeuroStar TMS Therapy System Neuronetics, Inc. | OBP |
| Mar 28, 2014 | K133408 | NEUROSTAR TMS THERAPY SYSTEM Neuronetics | OBP |
| Apr 30, 2013 | K130233 | NEUROSTAR TMS THERAPY SYSTEM Neuronetics | OBP |
| Dec 16, 2008 | K083538 | NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 Neuronetics | OBP |
| Oct 7, 2008 | DEN070003 | NEUROSTAR TMS SYSTEM Neuronetics | OBP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2026 | Neuronetics, Inc. NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems:
1. NeuroStar 2.0 US; Part Number: 81-01315-0 Open, Classified |
OBP | K231926 K233621 |
| May 27, 2009 | Neuronetics, Inc. NeuroStar TMS Therapy System/SenStar Treatment Link.
The SenStar Treatment Link is a single use, disposable component of the NeuroStar TMS system, a non-invasive treatment for depression using highly Terminated |
OBP | K083538 |