Product code GZB

Device name: Stimulator, Spinal-Cord, Implanted (Pain Relief)
Medical specialty: Neurology
Device class: 2
Regulation number: 882.5880
Review panel: NE
Implant: Y
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K233801	Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation	Boston Scientific Neuromodulation	2024-08-23
K221376	Nalu Neurostimulation System	Boston Scientific Neuromodulation	2022-06-10
K203547	Nalu Neurostimulation System	Boston Scientific Neuromodulation	2021-03-25
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, Patien...	Boston Scientific Neuromodulation	2020-11-09
K201618	Nalu Neurostimulation SCS system	Boston Scientific Neuromodulation	2020-07-15
K191466	SandShark Injectable Anchor (SIA) System	Stimwave Technologies, Inc.	2019-11-07
K190960	Nalu Lead Blank (50cm)	Boston Scientific Neuromodulation	2019-07-11
K182720	Freedom Spinal Cord Stimulator (SCS) System	Stimwave Technologies Incorporated	2019-03-29
K183047	Nalu Neurostimulation System	Boston Scientific Neuromodulation	2019-03-22
K180981	Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit	Stimwave Technologies Incorporated	2018-09-19
K172644	Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base	Stimwave Technologies Incorporated	2017-11-03
K170141	Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit	Stimwave Technologies Incorporated	2017-05-02
K162161	Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit	Stimwave Technologies Incorporated	2016-12-16
K160600	Freedom Spinal Cord Stimulator System	Stimwave Technologies Incorporated	2016-08-26
K150924	A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus ...	Anchor Innovation Medical (A.I.M.)	2015-07-27
K150517	Freedom Spinal Cord Stimulator System	Stimwave Technologies Incorporated	2015-06-05
K141399	FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM	Stimwave Technologies Incorporated	2014-10-10
K140272	SWIFT-LOCK ANCHOR	St Jude Medical	2014-05-02
K130545	MULTI LEAD TRIAL CABLE	St Jude Medical	2013-06-18
K123299	MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS	St. Jude Medical Neuromodulation	2013-01-18
K113611	RAPID PROGRAMMER	St Jude Medical	2012-04-20
K113805	FIXATE TISSUE BAND	Anulex Technologies, Inc.	2012-02-23
K113400	FIXATE TISSUE BAND	Anulex Technologies, Inc.	2011-12-16
K112214	OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS	St. Jude Medical Neuromodulation	2011-11-17
K112849	FIXATE TISSUE BAND	Anulex Technologies, Inc.	2011-10-27
K111462	FIXATE TISSUE BAND	Anulex Technologies, Inc.	2011-09-08
K102523	MULTI-LEAD TRIALING CABLE MODEL 355531	Medtronic, Inc.	2010-10-26
K092371	SWIFT-LOCK ANCHOR, MODEL 1192	Advanced Neuromodulation Systems	2009-12-23
K091993	RAPID PROGRAMMER, VERSION 3.3.0	Advanced Neuromodulation Systems, Inc. (Ans Inc.)	2009-07-31
K090907	PENTA LEAD KITS, MODELS: 3227-3234	Advanced Neuromodulation Systems	2009-06-02

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00812537037752	Nalu™ User Trial Kit	NALU MEDICAL, INC.	2026-05-27
10812537030095	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030279	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030262	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030255	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030217	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030200	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030187	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030170	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030163	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030156	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030149	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030132	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030125	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030118	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030101	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030088	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030071	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030064	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030057	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10812537030040	Nalu Medical, Inc.	NALU MEDICAL, INC.	2020-04-21
10681490078099	NA	MEDTRONIC, INC.	2015-11-17
08714729836827	Fixate ™	BOSTON SCIENTIFIC NEUROMODULATION CORPORATION	2015-11-09
10681490077924	NA	MEDTRONIC, INC.	2015-06-08
10681490077849	NA	MEDTRONIC, INC.	2015-06-08
M365FB101010	Fixate™ Suturing Device	BOSTON SCIENTIFIC NEUROMODULATION CORPORATION	2014-09-24
10681490102053	VERIFY®	MEDTRONIC, INC.	2014-09-23
10681490078051	NA	MEDTRONIC, INC.	2014-09-23
10681490077887	NA	MEDTRONIC, INC.	2014-09-23
10681490077139	NA	MEDTRONIC, INC.	2014-09-23

Product code GZB

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