Data / Medical devices / United States / Ad-Tech Medical Instrument Corp.

Ad-Tech Medical Instrument Corp.: FDA-registered device maker in Oak Creek, WI, United States, 11 510(k) clearances

Name: Ad-Tech Medical Instrument Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ad-Tech Medical Instrument Corp. is registered with the FDA (registration 2183456) in Oak Creek, WI, United States. It lists 17 device types. The FDA files 11 510(k) clearances under its listings, the newest dated May 18, 2023. 11 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2183456
Address: 400 West Oakview Parkway, Oak Creek, WI, United States, 53154
Owner or operator: AD-TECH MEDICAL INSTRUMENT CORP. (2183456)
Roles: Manufacturer
First device listed: April 25, 2001
Registered through: 2026
Brand names listed: AD-BAND Post-Op Headwrap, Ad-Tech Brain Biopsy Needles, Ad-Tech Cannulas, Ad-Tech Depth Electrodes, Ad-Tech Measuring Rulers, Ad-Tech Obturators, Ad-Tech Passing Needles, Ad-Tech Pin Crimper and more

Devices it lists

Device	Product code	Class	Role	Source
Biopsy Needle	FCG	2	Manufacturer	accessdata.fda.gov
Cable, Electrode	IKD	2	Manufacturer	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Manufacturer	accessdata.fda.gov
Crimper, Pin	HXQ	1	Manufacturer	accessdata.fda.gov
Device, Nerve Conduction Velocity Measurement	JXE	2	Manufacturer	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Manual)	HBG	2	Manufacturer	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)	HBE	2	Manufacturer	accessdata.fda.gov
Electrode, Cortical	GYC	2	Manufacturer	accessdata.fda.gov
Electrode, Depth	GZL	2	Manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Non-Powered	HAO	1	Manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Manufacturer	accessdata.fda.gov
Passer	HWQ	1	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Evoked Response	GWF	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve	ETN	2	Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Manufacturer	accessdata.fda.gov
Wrench	HXC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 18, 2023	K223276	Anchor Bolts as Accessories to Depth Electrodes	GZL	Substantially Equivalent	Ad-Tech Medical Instrument Corporation	accessdata.fda.gov
May 18, 2023	K223269	Spencer Probe Depth Electrodes	GZL	Substantially Equivalent	Ad-Tech Medical Instrument Corporation	accessdata.fda.gov
January 25, 2020	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	Ad-Tech Medical Instrument Corporation	accessdata.fda.gov
September 7, 2017	K170442	Cranial Drill Bits and Accessories	HBE	Substantially Equivalent	Ad-Tech Medical Instrument Corporation	accessdata.fda.gov
April 12, 2017	K163355	Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes	GZL	Substantially Equivalent	Ad-Tech Medical Instrument Corporation	accessdata.fda.gov
May 6, 2016	K152769	FREMAP ELECTRODE	ETN	Substantially Equivalent	Ad-Tech Medical Instrument Corporation	accessdata.fda.gov
March 4, 2016	K152547	DNAP Electrode	GZL	Substantially Equivalent	Ad-Tech Medical Instrument Corporation	accessdata.fda.gov
April 24, 2012	K112094	BRAIN BIOPSY NEEDLE	HAW	Substantially Equivalent	Ad-Tech Medical Instrument Corp	accessdata.fda.gov
June 10, 1998	K973454	AD-TECH'S SPINAL ELECTRODE	GZL	Substantially Equivalent	Ad-Tech Medical Instrument Corp	accessdata.fda.gov
January 20, 1995	K944061	CUEVA CRANIAL NERVE ELECTRODE	GZL	Substantially Equivalent	Ad-Tech Medical Instrument Corp	accessdata.fda.gov
November 23, 1992	K924348	AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC	HAW	Substantially Equivalent	Ad-Tech Medical Instrument Corp	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 19, 2024	95414	Class II	Completed	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	accessdata.fda.gov
August 9, 2021	88590	Class II	Terminated	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.	accessdata.fda.gov
August 27, 2019	83628	Class II	Terminated	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.	accessdata.fda.gov
June 18, 2019	83246	Class II	Terminated	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 blu	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 regulat	accessdata.fda.gov
June 18, 2019	83179	Class II	Terminated	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.	accessdata.fda.gov
April 16, 2019	82719	Class II	Terminated	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 El	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 elec	accessdata.fda.gov
May 2, 2018	80280	Class II	Terminated	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 ar	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.	accessdata.fda.gov
December 20, 2017	80002	Class II	Terminated	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	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.	accessdata.fda.gov
March 29, 2016	73685	Class II	Terminated	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)	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 in	accessdata.fda.gov
October 8, 2014	69436	Class II	Terminated	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-L	The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve..	accessdata.fda.gov
December 18, 2012	64136	Class I	Terminated	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 signal	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.	accessdata.fda.gov

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Updated October 24, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.