# Boston Scientific Neuromodulation

- Location (FDA's records): Valencia, CA
- FDA decisions: 11 (2015–2025): 10 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Boston Scientific Neuromodulation (10); Boston Scientific Neuromodulation Corporation (1)
- Product codes: GZB (7), GZF (2), NQO (1), GXD (1)
- 510(k) review time since 2016: median 98 days, against 149 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 10 (7 its own); citations of its devices by later devices: 11 (7 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cosman Medical, Inc.: 1 (https://510kreport.com/company/cosman-medical)
- Stimwave Technologies Inc., Dba Stimq, LLC: 1 (https://510kreport.com/company/stimwave-technologies-dba-stimq)
- Stimwave Technologies Incorporated: 1 (https://510kreport.com/company/stimwave-technologies)

## Firms that cite its devices most
- Bioventus, LLC: 2 (https://510kreport.com/company/bioventus)
- Nalu Medical, Inc.: 1 (https://510kreport.com/company/nalu-medical)
- Neuspera Medical, Inc.: 1 (https://510kreport.com/company/neuspera-medical)

## Its most-cited devices
- K183579: 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 (2019), cited by 5
- K183047: Nalu Neurostimulation System (2019), cited by 3
- K203547: Nalu Neurostimulation System (2021), cited by 1
- K221376: Nalu Neurostimulation System (2022), cited by 1
- K201618: Nalu Neurostimulation SCS system (2020), cited by 1

## Recent decisions
- K251247: GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) (Aug 7, 2025)
- K233801: Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation (Aug 23, 2024)
- K232415: Nalu Neurostimulation System for Peripheral Nerve Stimulation (Aug 21, 2024)
- K221376: Nalu Neurostimulation System (Jun 10, 2022)
- K203547: Nalu Neurostimulation System (Mar 25, 2021)
- K202274: Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits (Nov 9, 2020)
- K201618: Nalu Neurostimulation SCS system (Jul 15, 2020)
- K190960: Nalu Lead Blank (50cm) (Jul 11, 2019)

Source page: https://510kreport.com/company/boston-scientific-neuromodulation