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17ga, 105mm Always-On Tip Tracked Biopsy Needle, Chiba Point

Model INS-5017 · VERAN MEDICAL TECHNOLOGIES INC. · DI 00815686020224

JAK — System, X-Ray, Tomography, Computed · Class II · 21 CFR 892.1750

UDILibrary device dossier · generated 2026-09-13 · 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
2023-08-10Z-2663-2023Class IIOpen, ClassifiedNon-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environmentcode info di

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.

23572019-01: 0 reports for this device; peer average 5.1/device2019-02: 0 reports for this device; peer average 3.3/device2019-03: 0 reports for this device; peer average 3.25/device2019-04: 0 reports for this device; peer average 5.91/device2019-05: 0 reports for this device; peer average 3.25/device2019-06: 0 reports for this device; peer average 2.8/device2019-07: 0 reports for this device; peer average 2.58/device2019-08: 0 reports for this device; peer average 2.43/device2019-09: 0 reports for this device; peer average 2.14/device2019-10: 0 reports for this device; peer average 2.25/device2019-11: 0 reports for this device; peer average 1.86/device2019-12: 0 reports for this device; peer average 5.33/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 2.75/device2020-03: 0 reports for this device; peer average 2.2/device2020-04: 0 reports for this device; peer average 3.67/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2.44/device2020-07: 0 reports for this device; peer average 2.25/device2020-08: 0 reports for this device; peer average 1.74/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 2.05/device2020-11: 0 reports for this device; peer average 2.24/device2020-12: 0 reports for this device; peer average 2.4/device2021-01: 0 reports for this device; peer average 1.47/device2021-02: 0 reports for this device; peer average 1.81/device2021-03: 0 reports for this device; peer average 2.43/device2021-04: 0 reports for this device; peer average 2.74/device2021-05: 0 reports for this device; peer average 3.77/device2021-06: 0 reports for this device; peer average 4.55/device2021-07: 0 reports for this device; peer average 3.07/device2021-08: 0 reports for this device; peer average 2.53/device2021-09: 0 reports for this device; peer average 2.3/device2021-10: 0 reports for this device; peer average 1.67/device2021-11: 0 reports for this device; peer average 2.62/device2021-12: 0 reports for this device; peer average 2.75/device2022-01: 0 reports for this device; peer average 1.89/device2022-02: 0 reports for this device; peer average 2.47/device2022-03: 0 reports for this device; peer average 2.43/device2022-04: 0 reports for this device; peer average 2.42/device2022-05: 0 reports for this device; peer average 1.89/device2022-06: 0 reports for this device; peer average 1.88/device2022-07: 0 reports for this device; peer average 3.53/device2022-08: 0 reports for this device; peer average 1.86/device2022-09: 0 reports for this device; peer average 2.84/device2022-10: 0 reports for this device; peer average 2.09/device2022-11: 0 reports for this device; peer average 2.07/device2022-12: 0 reports for this device; peer average 1.65/device2023-01: 0 reports for this device; peer average 2.31/device2023-02: 0 reports for this device; peer average 1.9/device2023-03: 0 reports for this device; peer average 2.63/device2023-04: 0 reports for this device; peer average 2.17/device2023-05: 0 reports for this device; peer average 2.57/device2023-06: 0 reports for this device; peer average 6.84/device2023-07: 0 reports for this device; peer average 2.1/device2023-08: 0 reports for this device; peer average 3.42/device2023-09: 0 reports for this device; peer average 2.95/device2023-10: 0 reports for this device; peer average 5.89/device2023-11: 0 reports for this device; peer average 2.58/device2023-12: 0 reports for this device; peer average 2.9/device2024-01: 0 reports for this device; peer average 1.9/device2024-02: 0 reports for this device; peer average 1.88/device2024-03: 0 reports for this device; peer average 1.89/device2024-04: 0 reports for this device; peer average 1.65/device2024-05: 0 reports for this device; peer average 2.06/device2024-06: 0 reports for this device; peer average 3.08/device2024-07: 0 reports for this device; peer average 1.88/device2024-08: 0 reports for this device; peer average 1.3/device2024-09: 0 reports for this device; peer average 1.17/device2024-10: 0 reports for this device; peer average 1.95/device2024-11: 0 reports for this device; peer average 1.45/device2024-12: 0 reports for this device; peer average 1.69/device2025-01: 0 reports for this device; peer average 1.59/device2025-02: 0 reports for this device; peer average 1.61/device2025-03: 0 reports for this device; peer average 1.39/device2025-04: 0 reports for this device; peer average 1.86/device2025-05: 0 reports for this device; peer average 2.5/device2025-06: 0 reports for this device; peer average 1.54/device2025-07: 0 reports for this device; peer average 1.5/device2025-08: 0 reports for this device; peer average 1.5/device2025-09: 0 reports for this device; peer average 1.67/device2025-10: 0 reports for this device; peer average 1.1/device2025-11: 0 reports for this device; peer average 1.29/device2025-12: 0 reports for this device; peer average 2.41/device2026-01: 0 reports for this device; peer average 2.22/device2026-02: 0 reports for this device; peer average 1.68/device2026-03: 0 reports for this device; peer average 1.45/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 2.19/device2026-06: 0 reports for this device; peer average 1.55/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0105.1
2019-0203.3
2019-0303.25
2019-0405.91
2019-0503.25
2019-0602.8
2019-0702.58
2019-0802.43
2019-0902.14
2019-1002.25
2019-1101.86
2019-1205.33
2020-0102
2020-0202.75
2020-0302.2
2020-0403.67
2020-0502
2020-0602.44
2020-0702.25
2020-0801.74
2020-0902
2020-1002.05
2020-1102.24
2020-1202.4
2021-0101.47
2021-0201.81
2021-0302.43
2021-0402.74
2021-0503.77
2021-0604.55
2021-0703.07
2021-0802.53
2021-0902.3
2021-1001.67
2021-1102.62
2021-1202.75
2022-0101.89
2022-0202.47
2022-0302.43
2022-0402.42
2022-0501.89
2022-0601.88
2022-0703.53
2022-0801.86
2022-0902.84
2022-1002.09
2022-1102.07
2022-1201.65
2023-0102.31
2023-0201.9
2023-0302.63
2023-0402.17
2023-0502.57
2023-0606.84
2023-0702.1
2023-0803.42
2023-0902.95
2023-1005.89
2023-1102.58
2023-1202.9
2024-0101.9
2024-0201.88
2024-0301.89
2024-0401.65
2024-0502.06
2024-0603.08
2024-0701.88
2024-0801.3
2024-0901.17
2024-1001.95
2024-1101.45
2024-1201.69
2025-0101.59
2025-0201.61
2025-0301.39
2025-0401.86
2025-0502.5
2025-0601.54
2025-0701.5
2025-0801.5
2025-0901.67
2025-1001.1
2025-1101.29
2025-1202.41
2026-0102.22
2026-0201.68
2026-0301.45
2026-0402
2026-0502.19
2026-0601.55
This device (reports/month)Average device in JAK (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — VERAN MEDICAL TECHNOLOGIES INC.

  • VAI 2023-02-23 Veran Medical Technologies Inc · 4 citations
  • VAI 2021-07-29 Veran Medical Technologies Inc · 0 citations
  • VAI 2019-01-31 Veran Medical Technologies Inc · 0 citations
  • VAI 2018-02-23 Veran Medical Technologies Inc · 0 citations
  • NAI 2015-02-04 Veran Medical Technologies Inc · 0 citations
  • NAI 2010-08-25 Veran Medical Technologies Inc · 0 citations