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 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K905402 | ANTIGENZ CHLAMYDIA | Northumbria Biologicals , Ltd. | 1991-03-11 | Traditional | PDF ↗ |
| K903690 | MEDTRONIC (R) MODEL 3625 SCREENER | Medtronic Vascular | 1991-02-14 | Traditional | PDF ↗ |
| K910199 | MEDTRONIC MODEL 3487A PISCES-QUAD LEAD | Medtronic Vascular | 1991-02-11 | Traditional | PDF ↗ |
| K905407 | MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME | Medtronic Vascular | 1991-02-01 | Traditional | PDF ↗ |
| K905255 | NEUROMED MODEL 1992 LS LAMITRODE LEAD | Neuromed, Inc. | 1991-01-25 | Traditional | PDF ↗ |
| K903814 | NEUROMED TS8 TEST STIMULATOR | Neuromed, Inc. | 1991-01-16 | Traditional | PDF ↗ |
| K901499 | NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO. | Neuromed, Inc. | 1990-06-29 | Traditional | PDF ↗ |
| K890061 | MODEL 3586 RESUME LEAD | Medtronic Vascular | 1990-04-30 | Traditional | PDF ↗ |
| K892884 | MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION | Medtronic Vascular | 1989-08-07 | Traditional | PDF ↗ |
| K885033 | MODEL 3487A PISCES EPIDURAL LEAD | Medtronic Vascular | 1989-01-17 | Traditional | PDF ↗ |
| K884948 | MODEL 3587A RESUME EPIDURAL LEAD | Medtronic Vascular | 1989-01-17 | Traditional | PDF ↗ |
| K883780 | XTREL, MODEL NUMBER 3425 | Medtronic Vascular | 1988-11-30 | Traditional | PDF ↗ |
| K881491 | MODEL 3487A PISCES EPIDURAL LEAD | Medtronic Vascular | 1988-05-25 | Traditional | PDF ↗ |
| K873675 | MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD | Medtronic Vascular | 1987-10-06 | Traditional | PDF ↗ |
| K862915 | MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 CHANNEL) | Neuromed, Inc. | 1986-10-06 | Traditional | PDF ↗ |
| K855107 | MEDTRONIC MODEL 3422A TRANSMITTER ANTENNA KIT | Medtronic Vascular | 1986-05-09 | Traditional | PDF ↗ |
| K860185 | UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER | Neuromed, Inc. | 1986-04-04 | Traditional | PDF ↗ |
| K860158 | 8-CHANNEL MULTIPROG IMPLANT SPINAL CORD STIMULATOR | Neuromed, Inc. | 1986-03-07 | Traditional | PDF ↗ |
| K853643 | MULTISTIM LAMINECTOMY ELECTRODE | Neuromed, Inc. | 1985-11-14 | Traditional | PDF ↗ |
| K852326 | UNISTIM UNT-1 | Neuromed, Inc. | 1985-11-14 | Traditional | PDF ↗ |
| K852920 | QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF | Neuromed, Inc. | 1985-10-10 | Traditional | PDF ↗ |
| K852827 | CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A | Cordis Corp. | 1985-08-14 | Traditional | PDF ↗ |
| K844115 | MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL | Medtronic Vascular | 1985-02-06 | Traditional | PDF ↗ |
| K841584 | MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL | Medtronic Vascular | 1984-05-14 | Traditional | PDF ↗ |
| K833990 | SPINAL CORD STIMULATION SYS SE-4 | Medtronic Vascular | 1984-03-19 | Traditional | PDF ↗ |
| K833809 | NEURAL STIMULATOR MONITOR | Instromedix, Inc. | 1983-12-01 | Traditional | PDF ↗ |
| K831746 | PISCES #3487 EPIDURAL LEAD FOR SPINAL | Medtronic Vascular | 1983-08-11 | Traditional | PDF ↗ |
| K823530 | STIMUCORD EXTERNAL NEURAL STIM. 911A | Cordis Corp. | 1982-12-15 | Traditional | PDF ↗ |
| K820988 | MEDTRONIC #1992-2 DUAL RATE TRANSMITTER | Medtronic Vascular | 1982-06-23 | Traditional | PDF ↗ |
| K812155 | MEDTRONIC DUAL CHANNEL SPINAL CORD STIM | Medtronic Vascular | 1981-10-08 | Traditional | PDF ↗ |
| K812154 | MEDTRONIC #3484 PISCES EPIDURAL LEAD | Medtronic Vascular | 1981-08-20 | Traditional | PDF ↗ |
| K811655 | MYELOSTAT DORSAL CORD STIMULATOR | Medtronic Vascular | 1981-07-01 | Traditional | PDF ↗ |
| K810182 | PROGRAMMABLE SPINAL CORAL STIM. SYSTEM | Electronic Diagnostics, Inc. | 1981-04-03 | Traditional | PDF ↗ |
| K810319 | CORDIS STIMUCORD EXTERNAL NEUTRAL STIM | Cordis Corp. | 1981-02-19 | Traditional | PDF ↗ |
| K801384 | MYELOSTAT DORSAL CORD STIMULATOR, ETC. | Medtronic Vascular | 1980-07-08 | Traditional | PDF ↗ |
| K800193 | MEDTRONIC PISCES GENERATION II LEAD KIT | Medtronic Vascular | 1980-02-05 | Traditional | PDF ↗ |
| K790790 | PISCES-SELECTOR X | Medtronic Vascular | 1979-05-25 | Traditional | PDF ↗ |
| K780758 | NEUROLOGICAL SCREENING STIMULATOR M 3623 | Medtronic Vascular | 1978-05-19 | Traditional | PDF ↗ |
| K780001 | EPIDURAL LEAD - MODEL 3481 | Medtronic Vascular | 1978-01-17 | Traditional | PDF ↗ |
Product code GZB · Class II · Neurology. Data: openFDA.