Company ยท US
Boston Scientific Neuromodulation Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2025. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
26recalls (6 in 12 months)
9recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | 10 |
| GXI | Probe, Radiofrequency Lesion | 8 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 8 |
| NHL | Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | 4 |
| NQO | Prosthesis, Spinous Process Spacer/Plate | 3 |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | 2 |
| GXD | Generator, Lesion, Radiofrequency | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 7, 2025 | K251247 | GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Gener Boston Scientific Neuromodulation Corporation | GXD |
| Aug 23, 2024 | K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation Boston Scientific Neuromodulation | GZB |
| Aug 21, 2024 | K232415 | Nalu Neurostimulation System for Peripheral Nerve Stimulation Boston Scientific Neuromodulation | GZF |
| Jun 10, 2022 | K221376 | Nalu Neurostimulation System Boston Scientific Neuromodulation | GZB |
| Mar 25, 2021 | K203547 | Nalu Neurostimulation System Boston Scientific Neuromodulation | GZB |
| Nov 9, 2020 | K202274 | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Boston Scientific Neuromodulation | GZB |
| Jul 15, 2020 | K201618 | Nalu Neurostimulation SCS system Boston Scientific Neuromodulation | GZB |
| Jul 11, 2019 | K190960 | Nalu Lead Blank (50cm) Boston Scientific Neuromodulation | GZB |
| Mar 29, 2019 | K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8 Boston Scientific Neuromodulation | GZF |
| Mar 22, 2019 | K183047 | Nalu Neurostimulation System Boston Scientific Neuromodulation | GZB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2026 | Boston Scientific Neuromodulation Corporation Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System Open, Classified |
GZB | K233801 |
| Aug 5, 2026 | Boston Scientific Neuromodulation Corporation INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500;
INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator ( Open, Classified |
LGW | None listed |
| Jul 8, 2026 | Boston Scientific Neuromodulation Corporation Intracept Access Instruments, Description/REF:
INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035,
INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU,
INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045,
INTRACEPT ACCE Open, Classified |
GXI | K222281 |
| Jun 11, 2026 | Boston Scientific Neuromodulation Corporation Boston Scientific Model SC-4318, Clik X Anchor
REF: M365SC43180 Open, Classified |
LGW | None listed |
| Jun 11, 2026 | Boston Scientific Neuromodulation Corporation Boston Scientific TCN Electrodes:
REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in);
REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in)
REF:TCN-15, TCN Electrode, NITINOL, 15 Open, Classified |
GXI | K050084 K183177 |
| Jun 11, 2026 | Boston Scientific Neuromodulation Corporation Boston Scientific CSK Electrodes:
REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm)
REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm);
REF: CSK-TC Open, Classified |
GXI | K050084 K183177 |
| Sep 12, 2025 | Boston Scientific Neuromodulation Corporation Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09 Open, Classified |
NHL | None listed |
| Sep 2, 2025 | Boston Scientific Neuromodulation Corporation Superion IDS Kit
Superion Indirect Decompression System 8MM, VF Implant
101-9808
00884662000529
Superion Indirect Decompression System 10MM, VF Implant
101-9810
00884662000536
Superion Indirect Deco Open, Classified |
NQO | None listed |
| Aug 19, 2025 | Boston Scientific Neuromodulation Corporation Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual Open, Classified |
NHL | None listed |
| Aug 14, 2024 | Boston Scientific Neuromodulation Corporation WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320 Open, Classified |
LGW | None listed |
| May 24, 2024 | Boston Scientific Neuromodulation Corporation Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320 Open, Classified |
NHL | None listed |
| Jun 15, 2023 | Boston Scientific Neuromodulation Corporation Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual Open, Classified |
NQO | None listed |
| Nov 14, 2022 | Boston Scientific Neuromodulation Corporation Superion Indirect Decompression System (IDS)
Model Numbers and Size:
101-9808 - 8mm
01-9812 - 12mm
101-9814 - 14mm Open, Classified |
NQO | None listed |
| Apr 10, 2020 | Boston Scientific Neuromodulation Corporation Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensi Terminated |
GXI | K183177 |
| Apr 10, 2020 | Boston Scientific Neuromodulation Corporation Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are tempe Terminated |
GXI | K183177 |
| Apr 10, 2020 | Boston Scientific Neuromodulation Corporation Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sen Terminated |
GXI | K183177 |
| Apr 10, 2020 | Boston Scientific Neuromodulation Corporation Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are tempe Terminated |
GXI | K183177 |
| Apr 10, 2020 | Boston Scientific Neuromodulation Corporation Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sen Terminated |
GXI | K183177 |
| Apr 24, 2019 | Boston Scientific Neuromodulation Corporation Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the subthalamic nucleus Terminated |
NHL | None listed |
| Apr 24, 2019 | Boston Scientific Neuromodulation Corporation Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage:
Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spin Terminated |
LGW | None listed |
| Apr 24, 2019 | Boston Scientific Neuromodulation Corporation Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in the management of ch Terminated |
LGW | None listed |
| Apr 24, 2019 | Boston Scientific Neuromodulation Corporation The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of t Terminated |
LGW | None listed |
| Apr 24, 2019 | Boston Scientific Neuromodulation Corporation LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500.
Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electrical stimulation to th Terminated |
LGW | None listed |
| Apr 24, 2019 | Boston Scientific Neuromodulation Corporation Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350.
Package Contents:
Lead Extension Kit
(1) Lead Extension
(1) Hex Wrench
(1) Tunneling Tool Assembly
(1) Device Registration Form/ Terminated |
LGW | None listed |
| Apr 24, 2019 | Boston Scientific Neuromodulation Corporation ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700.
2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Steri Terminated |
LGW | None listed |
| Apr 16, 2010 | Boston Scientific Neuromodulation Corporation Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4 Terminated |
LGW | None listed |