Company ยท US
Ad-Tech Medical Instrument Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2023. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
17recalls (0 in 12 months)
12recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GZL | Electrode, Depth | 21 |
| GYC | Electrode, Cortical | 9 |
| IKD | Cable, Electrode | 4 |
| HAW | Neurological Stereotaxic Instrument | 2 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 2 |
| BTQ | Airway, Nasopharyngeal | 1 |
| ETN | Stimulator, Nerve | 1 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 1 |
| KNC | Table, Obstetric (And Accessories) | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 18, 2023 | K223276 | Anchor Bolts as Accessories to Depth Electrodes Ad-Tech Medical Instrument Corporation | GZL |
| May 18, 2023 | K223269 | Spencer Probe Depth Electrodes Ad-Tech Medical Instrument Corporation | GZL |
| Jan 25, 2020 | K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Ad-Tech Medical Instrument Corporation | GYC |
| Aug 9, 2018 | K181544 | Anchor Bolt (as an accessory to Depth Electrodes) Ad-Tech Medical Instrument Corporation | GZL |
| Sep 7, 2017 | K170442 | Cranial Drill Bits and Accessories Ad-Tech Medical Instrument Corporation | HBE |
| Apr 12, 2017 | K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes Ad-Tech Medical Instrument Corporation | GZL |
| May 6, 2016 | K152769 | FREMAP ELECTRODE Ad-Tech Medical Instrument Corporation | ETN |
| Mar 4, 2016 | K152547 | DNAP Electrode Ad-Tech Medical Instrument Corporation | GZL |
| Apr 24, 2012 | K112094 | BRAIN BIOPSY NEEDLE Ad-Tech Medical Instrument Corp | HAW |
| May 30, 2006 | K053363 | DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES Ad-Tech Medical Instrument Corp | GYC |
| May 25, 2006 | K053358 | DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES Ad-Tech Medical Instrument Corp | GZL |
| Aug 16, 2004 | K041604 | MACRO-MICRO DEPTH ELECTRODE Ad-Tech Medical Instrument Corp | GZL |
| Nov 2, 1999 | K990788 | AD-TECH'S FORAMEN OVALE ELECTRODE Ad-Tech Medical Instrument Corp | GZL |
| Sep 13, 1999 | K992194 | CORTICAL MAPPING UNIT, MODEL CMU Ad-Tech Medical Instrument Corp | GYC |
| Jun 10, 1998 | K973454 | AD-TECH'S SPINAL ELECTRODE Ad-Tech Medical Instrument Corp | GZL |
| May 9, 1997 | K970587 | AD-TECH SUBDURAL ELECTRODE Ad-Tech Medical Instrument Corp | GYC |
| May 9, 1997 | K964644 | AD-TECH'S DEPTH ELECTRODE Ad-Tech Medical Instrument Corp | GZL |
| Sep 19, 1995 | K940320 | AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS Ad-Tech Medical Instrument Corp | BTQ |
| Jan 20, 1995 | K944061 | CUEVA CRANIAL NERVE ELECTRODE Ad-Tech Medical Instrument Corp | GZL |
| Nov 23, 1992 | K924348 | AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC Ad-Tech Medical Instrument Corp | HAW |
| Oct 23, 1992 | K923803 | AD-TECH SUB DURAL ELECTRODEDS Ad-Tech Medical Instrument Corp | GYC |
| Jan 15, 1992 | K912760 | AD-TECH EPIDURAL PEG ELECTRODE Ad-Tech Medical Instrument Corp | GYC |
| Jul 27, 1989 | K891920 | AD-TECH'S DEPTH ELECTRODE Ad-Tech Medical Instrument Corp | GZL |
| Jan 14, 1987 | K864194 | PALMER OBSTETRIC BRACE Ad-Tech Medical Instrument Corp | KNC |
| Aug 25, 1986 | K861031 | WYLER SPHENOIDAL ELECTRODE Ad-Tech Medical Instrument Corp | GZL |
| Jul 30, 1985 | K850342 | WYLER SUBDURAL STRIP ELECTRODE Ad-Tech Medical Instrument Corp | GYC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2024 | Ad-Tech Medical Instrument Corporation AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode Completed |
GZL | K163355 |
| Oct 24, 2024 | Ad-Tech Medical Instrument Corporation AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode Completed |
GZL | K163355 |
| Oct 24, 2024 | Ad-Tech Medical Instrument Corporation AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode Completed |
GZL | K163355 |
| Aug 9, 2021 | Ad-Tech Medical Instrument Corporation Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators. Terminated |
IKD | None listed |
| Aug 9, 2021 | Ad-Tech Medical Instrument Corporation Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators. Terminated |
IKD | None listed |
| Aug 9, 2021 | Ad-Tech Medical Instrument Corporation Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators. Terminated |
IKD | None listed |
| Aug 27, 2019 | Ad-Tech Medical Instrument Corporation AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits:
(a) REF DSG-90-2.3N
(b) REF DSG-6.3-090-2.4N Terminated |
HBG | K170442 |
| Jun 18, 2019 | Ad-Tech Medical Instrument Corporation LSB Style Anchor Bolt. Labeled with the following parts:
13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor b Terminated |
GZL | K181544 |
| Jun 18, 2019 | Ad-Tech Medical Instrument Corporation Skull Anchor Bolts Terminated |
GZL | K181544 |
| Jun 18, 2019 | Ad-Tech Medical Instrument Corporation Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes Terminated |
GZL | K163355 |
| Jun 18, 2019 | Ad-Tech Medical Instrument Corporation Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes Terminated |
GYC | K053363 |
| Apr 16, 2019 | Ad-Tech Medical Instrument Corporation AD-TECH Spencer Probe Depth Electrode
Product Usage:
The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyle Terminated |
GZL | K163355 |
| May 2, 2018 | Ad-Tech Medical Instrument Corporation AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628.
Product Usage:
The d Terminated |
HBE | K170442 |
| Dec 20, 2017 | Ad-Tech Medical Instrument Corporation Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a st Terminated |
LXH | None listed |
| Apr 15, 2016 | Ad-Tech Medical Instrument Corporation Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models:
1. L-DCL-4DINX (4 contacts: 1 terminal block with 4 connectors each);
2. L-DCL-6DINX (6 contacts: 1 terminal Terminated |
IKD | None listed |
| Oct 21, 2014 | Ad-Tech Medical Instrument Corporation Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX .
Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Ele Terminated |
GZL | K944061 |
| Mar 2, 2013 | Ad-Tech Medical Instrument Corporation Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation Terminated |
GYC | K053363 |