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3mm Cueva Electrode Kit

Model CNE1-3KDINX · Ad-Tech Medical Instrument Corporation · DI 00841823100863

GZL — Electrode, Depth · Class II · 21 CFR 882.1330

UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (1)

InitiatedRecall #ClassStatusReasonLink basis
2014-10-08Z-0106-2015Class IITerminatedThe recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. .k number procode

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

12342019-01: 0 reports for this device; peer average 2.5/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1.5/device2019-05: 0 reports for this device; peer average 1.5/device2019-11: 0 reports for this device; peer average 1.2/device2019-12: 0 reports for this device; peer average 2.5/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 2.47/device2020-08: 0 reports for this device; peer average 1.33/device2020-09: 0 reports for this device; peer average 2.5/device2020-10: 0 reports for this device; peer average 1.33/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1.2/device2021-09: 0 reports for this device; peer average 1.25/device2021-10: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 2.5/device2022-06: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1.67/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 2.4/device2023-05: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 2.5/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1.75/device2024-01: 0 reports for this device; peer average 3/device2024-02: 0 reports for this device; peer average 2.5/device2024-03: 0 reports for this device; peer average 1.5/device2024-05: 0 reports for this device; peer average 3.75/device2024-07: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 1.5/device2024-10: 0 reports for this device; peer average 3/device2024-11: 0 reports for this device; peer average 2.25/device2024-12: 0 reports for this device; peer average 2.5/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 3/device2025-03: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 2.33/device2025-07: 0 reports for this device; peer average 2.5/device2026-01: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 3/device2026-06: 0 reports for this device; peer average 2.5/device01030405111201020809101112030408091005060911010203050611120102030507091011120102030507010506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.5
2019-0301
2019-0401.5
2019-0501.5
2019-1101.2
2019-1202.5
2020-0102
2020-0202.47
2020-0801.33
2020-0902.5
2020-1001.33
2020-1101
2020-1201
2021-0301
2021-0401
2021-0801.2
2021-0901.25
2021-1001
2022-0502.5
2022-0601
2022-0901
2022-1101
2023-0101.67
2023-0201
2023-0302.4
2023-0501
2023-0602.5
2023-1101
2023-1201.75
2024-0103
2024-0202.5
2024-0301.5
2024-0503.75
2024-0702
2024-0901.5
2024-1003
2024-1102.25
2024-1202.5
2025-0102
2025-0203
2025-0302
2025-0502.33
2025-0702.5
2026-0101
2026-0503
2026-0602.5
This device (reports/month)Average device in GZL (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K944061 — cited as predicate by K152547, K152769, K163355, K230853

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Ad-Tech Medical Instrument Corporation

  • Warning Letter 2013-11-14 Ad-Tech Medical Instrument Corporation
  • Warning Letter 2013-11-14 Ad-Tech Medical Instrument Corporation
  • Warning Letter 2012-04-12 Ad-Tech Medical Instrument Corporation
  • Warning Letter 2012-04-12 Ad-Tech Medical Instrument Corporation
  • VAI 2022-04-07 Ad-Tech Medical Instrument Corporation · 0 citations
  • VAI 2022-04-07 Ad-Tech Medical Instrument Corporation · 0 citations
  • VAI 2019-06-27 Ad-Tech Medical Instrument Corporation · 12 citations
  • VAI 2019-06-27 Ad-Tech Medical Instrument Corporation · 12 citations
  • VAI 2017-09-05 Ad-Tech Medical Instrument Corporation · 5 citations
  • VAI 2017-09-05 Ad-Tech Medical Instrument Corporation · 5 citations
  • NAI 2014-06-20 Ad-Tech Medical Instrument Corporation · 0 citations
  • NAI 2014-06-20 Ad-Tech Medical Instrument Corporation · 0 citations
  • OAI 2013-06-05 Ad-Tech Medical Instrument Corporation · 7 citations
  • OAI 2013-06-05 Ad-Tech Medical Instrument Corporation · 7 citations
  • VAI 2012-11-26 Ad-Tech Medical Instrument Corporation · 5 citations
  • VAI 2012-11-26 Ad-Tech Medical Instrument Corporation · 5 citations
  • OAI 2012-01-11 Ad-Tech Medical Instrument Corporation · 0 citations
  • OAI 2012-01-11 Ad-Tech Medical Instrument Corporation · 0 citations
  • VAI 2011-02-24 Ad-Tech Medical Instrument Corporation · 9 citations
  • VAI 2011-02-24 Ad-Tech Medical Instrument Corporation · 9 citations