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Unnamed device

Model PSP1002 · MEDTRONIC XOMED, INC. · DI 20613994802518

GXZ — Electrode, Needle · Class II · 21 CFR 882.1350

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

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 1.25/device2019-02: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1.13/device2019-05: 0 reports for this device; peer average 1.33/device2019-06: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1.25/device2021-01: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 2/device2022-07: 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 2/device2023-01: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1.17/device2023-06: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1.5/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1.33/device2024-06: 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 1/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 4/device2025-02: 0 reports for this device; peer average 1.33/device2025-03: 0 reports for this device; peer average 1.25/device2025-04: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 4/device2025-08: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1.86/device2026-01: 0 reports for this device; peer average 1.5/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1.83/device2026-04: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 2/device01020405060910111204010711120305060709110102030608101201020306091012010203040607080910120102030405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.25
2019-0201
2019-0401.13
2019-0501.33
2019-0601
2019-0902
2019-1001
2019-1101
2019-1201
2020-0401.25
2021-0102
2021-0701
2021-1101
2021-1201
2022-0301
2022-0502
2022-0602
2022-0701
2022-0901
2022-1102
2023-0101
2023-0201
2023-0301.17
2023-0601
2023-0801
2023-1001.5
2023-1201
2024-0101
2024-0201
2024-0301.33
2024-0602
2024-0901.5
2024-1001
2024-1202
2025-0104
2025-0201.33
2025-0301.25
2025-0402
2025-0601
2025-0704
2025-0801
2025-0901
2025-1001
2025-1201.86
2026-0101.5
2026-0201
2026-0301.83
2026-0401
2026-0502
This device (reports/month)Average device in GXZ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K062996 — cited as predicate by K103128, K110419, K112426

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

Manufacturer compliance record — MEDTRONIC XOMED, INC.

  • VAI 2024-06-17 Medtronic Xomed, Inc. · 1 citations
  • VAI 2021-10-29 Medtronic Xomed, Inc. · 5 citations
  • VAI 2015-09-21 Medtronic Xomed, Inc. · 1 citations
  • VAI 2012-07-03 Medtronic Xomed, Inc. · 8 citations
  • NAI 2012-06-06 Medtronic Xomed, Inc. · 0 citations
  • VAI 2010-08-05 Medtronic Xomed, Inc. · 4 citations