FDA Product Code
FDA Product Code GZB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5880
510(k) Clearances — 139 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation | Boston Scientific Neuromodulation | 2024-08-23 | Traditional | PDF ↗ |
| K221376 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2022-06-10 | Special | PDF ↗ |
| K203547 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2021-03-25 | Traditional | PDF ↗ |
| 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 | Boston Scientific Neuromodulation | 2020-11-09 | Traditional | PDF ↗ |
| K201618 | Nalu Neurostimulation SCS system | Boston Scientific Neuromodulation | 2020-07-15 | Special | PDF ↗ |
| K191466 | SandShark Injectable Anchor (SIA) System | Stimwave Technologies, Inc. | 2019-11-07 | Traditional | PDF ↗ |
| K190960 | Nalu Lead Blank (50cm) | Boston Scientific Neuromodulation | 2019-07-11 | Traditional | PDF ↗ |
| K182720 | Freedom Spinal Cord Stimulator (SCS) System | Stimwave Technologies Incorporated | 2019-03-29 | Traditional | PDF ↗ |
| K183047 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2019-03-22 | Traditional | PDF ↗ |
| K180981 | Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit | Stimwave Technologies Incorporated | 2018-09-19 | Traditional | PDF ↗ |
| K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base | Stimwave Technologies Incorporated | 2017-11-03 | Traditional | PDF ↗ |
| K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit | Stimwave Technologies Incorporated | 2017-05-02 | Traditional | PDF ↗ |
| K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit | Stimwave Technologies Incorporated | 2016-12-16 | Traditional | PDF ↗ |
| K160600 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2016-08-26 | Traditional | PDF ↗ |
| 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 Tension Assist/Suture Cutter Device | Anchor Innovation Medical (A.I.M.) | 2015-07-27 | Traditional | PDF ↗ |
| K150517 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2015-06-05 | Traditional | PDF ↗ |
| K141399 | FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM | Stimwave Technologies Incorporated | 2014-10-10 | Traditional | PDF ↗ |
| K140272 | SWIFT-LOCK ANCHOR | St Jude Medical | 2014-05-02 | Traditional | PDF ↗ |
| K130545 | MULTI LEAD TRIAL CABLE | St Jude Medical | 2013-06-18 | Traditional | PDF ↗ |
| K123299 | MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS | St. Jude Medical Neuromodulation | 2013-01-18 | Traditional | PDF ↗ |
| K113611 | RAPID PROGRAMMER | St Jude Medical | 2012-04-20 | Traditional | PDF ↗ |
| K113805 | FIXATE TISSUE BAND | Anulex Technologies, Inc. | 2012-02-23 | Traditional | PDF ↗ |
| K113400 | FIXATE TISSUE BAND | Anulex Technologies, Inc. | 2011-12-16 | Special | PDF ↗ |
| K112214 | OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS | St. Jude Medical Neuromodulation | 2011-11-17 | Traditional | PDF ↗ |
| K112849 | FIXATE TISSUE BAND | Anulex Technologies, Inc. | 2011-10-27 | Special | PDF ↗ |
| K111462 | FIXATE TISSUE BAND | Anulex Technologies, Inc. | 2011-09-08 | Traditional | PDF ↗ |
| K102523 | MULTI-LEAD TRIALING CABLE MODEL 355531 | Medtronic, Inc. | 2010-10-26 | Special | PDF ↗ |
| K092371 | SWIFT-LOCK ANCHOR, MODEL 1192 | Advanced Neuromodulation Systems | 2009-12-23 | Traditional | PDF ↗ |
| K091993 | RAPID PROGRAMMER, VERSION 3.3.0 | Advanced Neuromodulation Systems, Inc. (Ans Inc.) | 2009-07-31 | Special | PDF ↗ |
| K090907 | PENTA LEAD KITS, MODELS: 3227-3234 | Advanced Neuromodulation Systems | 2009-06-02 | Traditional | PDF ↗ |
| K081208 | CINCH ANCHOR, MODEL 1194 | Advanced Neuromodulation Systems | 2008-07-18 | Traditional | PDF ↗ |
| K072462 | WIDE SPACED QUATTRODE LEADS | Advanced Neuromodulation Systems | 2007-10-11 | Special | PDF ↗ |
| K070847 | TRIAL CABLE, 3009 | Advanced Neuromodulation Systems | 2007-04-11 | Special | PDF ↗ |
| K063080 | TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS | Advanced Neuromodulation Systems | 2006-12-12 | Special | PDF ↗ |
| K062041 | MODEL 3875 1 X 8 SC TEST STIMULATION LEAD | Medtronic, Inc. | 2006-08-16 | Special | PDF ↗ |
| K053250 | ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT | Advanced Neuromodulation Systems | 2005-12-15 | Special | PDF ↗ |
| K052374 | RAPID PROGEAMMER 3.0 | Advanced Neuromodulation Systems | 2005-11-22 | Traditional | PDF ↗ |
| K052418 | AXXESS BUTTERFLY ANCHOR | Advanced Neuromodulation Systems | 2005-09-26 | Special | PDF ↗ |
| K051773 | MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS | Medtronic Inc.,Neurological Division. | 2005-07-28 | Special | PDF ↗ |
| K050922 | ANS SCS ACCESSORY KIT | Advanced Neuromodulation Systems | 2005-05-18 | Special | PDF ↗ |
| K050633 | TRIAL CABLE RETENTION CLIP | Advanced Neuromodulation Systems | 2005-04-21 | Special | PDF ↗ |
| K040568 | POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS | Medtronic Vascular | 2004-03-25 | Special | PDF ↗ |
| K040609 | RAPID PROGRAMMER | Advanced Neuromodulation Systems | 2004-03-25 | Special | PDF ↗ |
| K033757 | MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM | Advanced Neuromodulation Systems | 2004-01-30 | Traditional | PDF ↗ |
| K033429 | LAMITRODE SPINAL CORD STIMULATION LEADS | Advanced Neuromodulation Systems | 2003-12-04 | Special | PDF ↗ |
| K033016 | PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892 | Medtronic Neurological | 2003-10-30 | Traditional | PDF ↗ |
| K032751 | MODIFICATION TO RENEW LEAD EXTENSION | Advanced Neuromodulation Systems | 2003-10-06 | Special | PDF ↗ |
| K032034 | ANS AXXESS PERCUTANEOUS LEAD | Advanced Neuromodulation Systems | 2003-10-03 | Traditional | PDF ↗ |
| K032349 | PLACER | Advanced Neuromodulation Systems | 2003-10-03 | Traditional | PDF ↗ |
| K032561 | RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR | Medtronic Vascular | 2003-09-11 | Special | PDF ↗ |
| K030461 | A127 LEAD EXTENSION | Advanced Neuromodulation Systems | 2003-04-24 | Traditional | PDF ↗ |
| K030674 | MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD | Advanced Neuromodulation Systems | 2003-03-28 | Special | PDF ↗ |
| K030118 | RAPID PROGRAMMAR | Advanced Neuromodulation Systems | 2003-03-11 | Traditional | PDF ↗ |
| K022222 | LAMITRODE S-SERIES (S4 AND S8) LEADS | Advanced Neuromodulation System,Inc | 2002-08-08 | Special | PDF ↗ |
| K021518 | PAINDOC | Advanced Neuromodulation Systems | 2002-06-06 | Special | PDF ↗ |
| K013120 | PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 | Medamicus, Inc. | 2002-01-24 | Traditional | PDF ↗ |
| K013063 | GRIP LOCK ANCHOR, MODEL 411374 | Medtronic Neurological | 2001-12-11 | Traditional | PDF ↗ |
| K010300 | MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION | Medtronic Vascular | 2001-08-01 | Traditional | PDF ↗ |
| K010008 | AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX | Micronet Medical, Inc. | 2001-07-16 | Traditional | PDF ↗ |
| K011584 | MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF | Medtronic Vascular | 2001-06-22 | Traditional | PDF ↗ |
| K000445 | MEDTRONIC MODEL 7499 EXTENSION | Medtronic Vascular | 2000-04-28 | Traditional | PDF ↗ |
| K994097 | MEDAMICUS EPIDURAL INTRODUCER | Medamicus, Inc. | 2000-03-01 | Traditional | PDF ↗ |
| K992946 | RENEW RECEIVER | Advanced Neuromodulation Systems | 1999-09-24 | Special | PDF ↗ |
| K991784 | RENEW LEAD EXTENSION | Advanced Neuromodulation Systems | 1999-06-24 | Special | PDF ↗ |
| K990469 | LAMITRODE LEADS | Advanced Neuromodulation Systems | 1999-06-03 | Traditional | PDF ↗ |
| K990104 | MEDTRONIC MODEL 7495 EXTENSION KIT | Medtronic Vascular | 1999-02-09 | Special | PDF ↗ |
| K972906 | MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA) | Medtronic Vascular | 1998-02-06 | Traditional | PDF ↗ |
| K971756 | MEDTRONIC MODEL 3998 LEAD | Medtronic Vascular | 1998-02-03 | Traditional | PDF ↗ |
| K972043 | MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER | Medtronic Vascular | 1997-08-22 | Traditional | PDF ↗ |
| K964172 | MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL | Medtronic Vascular | 1997-07-03 | Traditional | PDF ↗ |
| K953742 | BIFURCATED Y-EXTENSION | Medtronic Vascular | 1996-11-19 | Traditional | PDF ↗ |
| K960728 | ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE) | Neuromed, Inc. | 1996-05-22 | Traditional | PDF ↗ |
| K955291 | DUALSCREEN | Medtronic Vascular | 1996-05-17 | Traditional | PDF ↗ |
| K954886 | MODEL NOS. 7495 AND 501826 EXTENSIONS | Medtronic Vascular | 1995-11-27 | Traditional | PDF ↗ |
| K941342 | PAIN DOC | Regulatory & Marketing Services, Inc. | 1995-10-13 | Traditional | PDF ↗ |
| K952459 | MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL | Medtronic Vascular | 1995-08-30 | Traditional | PDF ↗ |
| K943537 | MODEL 3470 X-TREL RF RECEIVER | Medtronic Vascular | 1995-04-12 | Traditional | PDF ↗ |
| K934065 | MEDTRONIC MATTRIX 3271/3272 NEUROSTIMULATION SYSTEM | Medtronic Vascular | 1995-02-14 | Traditional | PDF ↗ |
| K950127 | ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY | Medtronic Vascular | 1995-01-30 | Traditional | PDF ↗ |
| K945103 | TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS) | Medtronic Vascular | 1995-01-11 | Traditional | PDF ↗ |
| K930536 | NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC | Neuromed, Inc. | 1994-12-15 | Traditional | PDF ↗ |
| K930498 | NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN | Neuromed, Inc. | 1994-12-12 | Traditional | PDF ↗ |
| K940416 | NEUROLOGICAL LEADS (PACKAGING MODIFICATION) | Medtronic Vascular | 1994-07-18 | Traditional | PDF ↗ |
| K936099 | NEUROLOGICAL LEAD ACCESSORIES | Medtronic Vascular | 1994-07-11 | Traditional | PDF ↗ |
| K934938 | TEMPORARY SCREENING LEAD/CATHETER KIT | Medtronic Vascular | 1994-06-14 | Traditional | PDF ↗ |
| K932202 | MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT | Medtronic Vascular | 1994-05-04 | Traditional | PDF ↗ |
| K932948 | MEDTRONIC MODEL 3625 SCREENER SYSTEM | Medtronic Vascular | 1994-02-03 | Traditional | PDF ↗ |
| K930242 | INTRODE INT-8 | Neuromed, Inc. | 1994-02-02 | Traditional | PDF ↗ |
| K921319 | NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30 | Neuromed, Inc. | 1993-05-05 | Traditional | PDF ↗ |
| K924522 | MEDTRONIC MODEL 3080 PISCES-QUAD LEAD | Medtronic Vascular | 1993-03-18 | Traditional | PDF ↗ |
| K923931 | MEDTRONIC MODEL 3487A PISCES-QUAD LEAD | Medtronic Vascular | 1993-03-18 | Traditional | PDF ↗ |
| K923567 | MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD | Medtronic Vascular | 1992-11-05 | Traditional | PDF ↗ |
| K921558 | MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS | Medtronic Vascular | 1992-07-07 | Traditional | PDF ↗ |
| K913993 | MEDTRONIC MODELS 3982 A,B,C&D STAG ARRAY RES LEADS | Medtronic Vascular | 1992-02-07 | Traditional | PDF ↗ |
| K913934 | MEDTRONIC MODEL 3586 RESUME LEAD | Medtronic Vascular | 1992-01-22 | Traditional | PDF ↗ |
| K914433 | MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS | Medtronic Vascular | 1991-12-23 | Traditional | PDF ↗ |
| K912764 | MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT | Medtronic Vascular | 1991-11-22 | Traditional | PDF ↗ |
| K913442 | MEDTRONIC 3625 SCREENER SYSTEM | Medtronic Vascular | 1991-11-22 | Traditional | PDF ↗ |
| K905569 | ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A | Biomedical Life Systems, Inc. | 1991-06-27 | Traditional | PDF ↗ |
| K905596 | NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST | Neuromed, Inc. | 1991-03-11 | Traditional | PDF ↗ |
Product code GZB · Class II · Neurology. Data: openFDA.