Atlas FDA

GZF

24 FDA 510(k) clearances · Product code

175 daysmedian time to decision
339 days90th percentile
24clearances measured

FDA profile

Official device name
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5870
Medical specialty
Neurology
Flags
Implant
Adverse events (MAUDE)
2021: 226 · 2022: 183 · 2023: 524 · 2024: 678 · 2025: 602 · 2026: 253
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
StimTrial Neuromodulation System (K243782)Bioventus, LLC2025-07-16
TalisMann Neuromodulation System (K243678)Bioventus, LLC2025-07-03
Nalu Neurostimulation System for Peripheral Nerve Stimulation (K232415)Boston Scientific Neuromodulation2024-08-21
Freedom Peripheral Nerve Stimulator (PNS) System (K233162)Curonix2024-06-20
Neuspera Nuity System (K221303)Neuspera Medical, Inc.2023-04-11
StimRouter Neuromodulation System (K211965)Bioness, Inc.2022-02-23
Neuspera Neurostimulation System (NNS) (K202781)Neuspera Medical, Inc.2021-08-27
Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit (K200848)Micron Medical Corporation2020-08-14
StimRouter Neuromodulation System (K200482)Bioness, Inc.2020-03-27
StimRouter Neuromodulation System (K190047)Bioness, Inc.2019-10-31
IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 (K191435)Nalu Medical, Inc.2019-09-06
Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits (K183579)Boston Scientific Neuromodulation2019-03-29
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit (K171366)Stimwave Technologies Inc., Dba Stimq, LLC2017-08-04
StimQ Peripheral Nerve Stimulator (PNS) System (K152178)Stimq, LLC2016-03-11
StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit (K142432)Bioness, Inc.2015-02-20
RENEW NEUROSTIMULATION SYSTEM (K000852)Advanced Neuromodulation Systems2001-01-19
MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), (K000105)Medtronic Vascular2000-04-12
PERIPHERAL NERVE STIMULATION (K982902)Medtronic Vascular1998-11-10
MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX (K960631)Medtronic Vascular1996-05-21
TECOTHANE 55D (K950425)Medtronic Vascular1995-04-19
MEDTRONIC MODEL 3990 PNS LEAD (K925952)Medtronic Vascular1993-08-20
MODELS 3987 AND 3988 RESUME LEAD FOR PNS (K920567)Medtronic Vascular1992-05-20
MODEL 3587A RESUME II LEAD (K915540)Medtronic Vascular1992-01-22
MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER (K904409)Medtronic Vascular1991-01-30

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Every clearance here is in the API, with alerts when new ones post.