Chrysalis Intelligence · Sponsors · Ad-Tech Medical Instrument Corporation

Ad-Tech Medical Instrument Corporation

Oak Creek, WI, US · 3 510(k) clearances · 6 recalls

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Total clearances
3
2020-01-25 → 2023-05-18
Last 12 months
0
Product codes
2
Most recent
2023-05-18
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GZL Electrode, Depth Class II Neurology 2 2023-05-18
GYC — — — 1 2020-01-25
Safety

Recalls (6)

Class I (serious)
0
Risk of injury / death
Total recalls
6
Currently ongoing
0
Most recent
2024-09-19
DateSeverityStatusRecall # ProductCodeReason
2024-09-19 Class II Completed 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 symb…
2024-09-19 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 symb…
2024-09-19 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 symb…
2021-08-09 Class II Terminated Z-2496-2021 Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes to third party monitor… — Incorrect version of labels were used.
2021-08-09 Class II Terminated Z-2495-2021 Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third … — Incorrect version of labels were used.
2021-08-09 Class II Terminated Z-2494-2021 Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party… — Incorrect version of labels were used.
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2023-05-18 K223276 Anchor Bolts as Accessories to Depth Electrodes GZL Class II Neurology
2023-05-18 K223269 Spencer Probe Depth Electrodes GZL Class II Neurology
2020-01-25 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 — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence