AD-Tech Medical Instrument Corp.
Oak Creek, WI, US
AD-TECH MEDICAL INSTRUMENT CORP. appears in FDA device records in Oak Creek, WI. FDA records list 26 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 17 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 26 510(k) clearances for AD-Tech Medical Instrument Corp. between 1985 and 2023. The busiest year on record is 1992, with 3. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 1 |
| 1989 | 1 |
| 1992 | 3 |
| 1995 | 2 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 2 |
| 2004 | 1 |
| 2006 | 2 |
| 2012 | 1 |
| 2016 | 2 |
| 2017 | 2 |
| 2018 | 1 |
| 2020 | 1 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223276 | Anchor Bolts as Accessories to Depth Electrodes | GZL | Substantially Equivalent | |
| K223269 | Spencer Probe Depth Electrodes | GZL | Substantially Equivalent | |
| K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode | GYC | Substantially Equivalent | |
| K181544 | Anchor Bolt (as an accessory to Depth Electrodes) | GZL | Substantially Equivalent | |
| K170442 | Cranial Drill Bits and Accessories | HBE | Substantially Equivalent | |
| K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes | GZL | Substantially Equivalent | |
| K152769 | FREMAP ELECTRODE | ETN | Substantially Equivalent | |
| K152547 | DNAP Electrode | GZL | Substantially Equivalent | |
| K112094 | BRAIN BIOPSY NEEDLE | HAW | Substantially Equivalent | |
| K053363 | DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES | GYC | Substantially Equivalent | |
| K053358 | DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES | GZL | Substantially Equivalent | |
| K041604 | MACRO-MICRO DEPTH ELECTRODE | GZL | Substantially Equivalent | |
| K990788 | AD-TECH'S FORAMEN OVALE ELECTRODE | GZL | Substantially Equivalent | |
| K992194 | CORTICAL MAPPING UNIT, MODEL CMU | GYC | Substantially Equivalent | |
| K973454 | AD-TECH'S SPINAL ELECTRODE | GZL | Substantially Equivalent | |
| K970587 | AD-TECH SUBDURAL ELECTRODE | GYC | Substantially Equivalent | |
| K964644 | AD-TECH'S DEPTH ELECTRODE | GZL | Substantially Equivalent | |
| K940320 | AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS | BTQ | Substantially Equivalent | |
| K944061 | CUEVA CRANIAL NERVE ELECTRODE | GZL | Substantially Equivalent | |
| K924348 | AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC | HAW | Substantially Equivalent | |
| K923803 | AD-TECH SUB DURAL ELECTRODEDS | GYC | Substantially Equivalent | |
| K912760 | AD-TECH EPIDURAL PEG ELECTRODE | GYC | Substantially Equivalent | |
| K891920 | AD-TECH'S DEPTH ELECTRODE | GZL | Substantially Equivalent | |
| K864194 | PALMER OBSTETRIC BRACE | KNC | Substantially Equivalent | |
| K861031 | WYLER SPHENOIDAL ELECTRODE | GZL | Substantially Equivalent | |
| K850342 | WYLER SUBDURAL STRIP ELECTRODE | GYC | Substantially Equivalent for Some Indications |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2183456 | 2183456 | AD-TECH MEDICAL INSTRUMENT CORP. | 400 West Oakview Parkway, Oak Creek, WI 53154 US | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- BTQAirway, Nasopharyngeal
- FCGBiopsy Needle
- IKDCable, Electrode
- GEACannula, Surgical, General & Plastic Surgery
- HXQCrimper, Pin
- JXEDevice, Nerve Conduction Velocity Measurement
- HBGDrills, Burrs, Trephines & Accessories (Manual)
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- GYCElectrode, Cortical
- GZLElectrode, Depth
- FZXGuide, Surgical, Instrument
- HAOInstrument, Surgical, Non-Powered
- HAWNeurological Stereotaxic Instrument
- HWQPasser
- GWFStimulator, Electrical, Evoked Response
- ETNStimulator, Nerve
- KNCTable, Obstetric (And Accessories)
- FTYTape, Measuring, Rulers And Calipers
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0221-2025 | AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above. | Class II | Completed | |
| Z-0220-2025 | AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above. | Class II | Completed | |
| Z-0219-2025 | AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above. | Class II | Completed | |
| Z-2496-2021 | Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators. | Incorrect version of labels were used. | Class II | Terminated | |
| Z-2495-2021 | Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators. | Incorrect version of labels were used. | Class II | Terminated | |
| Z-2494-2021 | Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators. | Incorrect version of labels were used. | Class II | Terminated | |
| Z-2544-2019 | 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 | The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery. | Class II | Terminated | |
| Z-2204-2019 | 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 bolt cap containing a blue gasket and silicone cap, 13mm non-anodized anchor bolt body with anchor bolt cap containing a green gasket and silicone cap, 26mm non-anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap - Product Usage: The Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode. Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes. | On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 and May 31, 2019 Ad-Tech personnel have distributed non-sterile anchor bolt parts to one independent representative and one international distributor, who may have subsequently sterilized the non-sterile anchor bolts for clinical use. Ad-Tech does not have regulatory clearance to distribute non-sterile anchor bolts and does not have a validated hospital sterilization method for these devices. Further, Ad-Tech labeling does not include instructions for sterilizing anchor bolts. | Class II | Terminated | |
| Z-2408-2019 | Skull Anchor Bolts | Supplemental information provided with devices may indicate that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use. | Class II | Terminated | |
| Z-2407-2019 | Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes | Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use. | Class II | Terminated | |
| Z-2406-2019 | Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes | Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use. | Class II | Terminated | |
| Z-2396-2019 | 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, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping. | An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an issue after implanting four Ad-Tech depth electrodes. Upon initial device testing subsequent to implantation it was identified that two of the devices that were labeled as 8 contact depth electrodes (SD08R-SP05X-000) were in fact 6 contact depth electrodes (SD06R-SP05X-000) . There was no impact to the patient due to this incident. | Class II | Terminated | |
| Z-2539-2018 | 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 drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement. The DSG-6.3-090-2.4N drill sleeve guides are intended to be used with the 2.4mm Cranial Drill Bit diameter. | The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery. | Class II | Terminated | |
| Z-1938-2018 | 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 sterile state and are single-use only. Used to drill cranial holes using a stereotactic frame. | There is a possibility that DDK2-2.4-30X Disposable Drill Kits, Lot Number 111664 208140649 contained 2.8mm drill bits from DDK2-2.8-30X Disposable Drill Kits, Lot Number 111745 208140649 and vice versa. | Class II | Terminated | |
| Z-1503-2016 | 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 block with 6 connectors each); 3. L-DCL-8DINX (8 contacts: 1 terminal block with 8 connectors each); 4. L-DCL-16BDINX (16 contacts: 1 terminal block with 16 connectors each); 5. L-DCL-32BDINX (32 contacts: 2 terminal blocks with 16 connectors each); 6. L-DCL-64BDINX (64 contacts: 4 terminal blocks with 16 connectors each). FO TECH-ATTACH Connection Cable model FO-LDC-4DINX (4 contacts: 1 terminal block with 4 connectors each). Tech-Attach: these cables require the use of an additional component - the connector block. The tail of the electrode is inserted into the block and the block in turn mates with the cable. A key-pin is used to ensure proper orientation. The cable terminated in EEG compatible connector sockets. Lightweight CABRIO Cable, model L-SRL-64BDINX (64 contacts: 4 terminal blocks with 16 connectors each). Cabrio cables are similar to Tech-Attach cables except that the block portion is pre-attached. The tail of an electrode is inserted into this portion which then hinges shut. | Ad-Tech is recalling unopened/unused sterile cables intended to be used only with all compatible Ad-Tech electrodes for the purpose of connecting these electrodes to third party monitors/stimulators. This recall has been initiated due to package failures (i.e. compromised sterile barriers) that were identified during the execution of a shipping simulation investigation. | Class II | Terminated | |
| Z-0106-2015 | 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 Electrode Leadwire CNE-LW-2DINX. Box Label: 2 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-2KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-2X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. | The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. . | Class II | Terminated | |
| Z-0892-2013 | 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 of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping. | The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces which may fracture and remain in the cortical tissue with the electrode is explanted. Recall expanded on 5/2/2013 to include additional Macro Micro Subdural Electrodes. | Class I | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain