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Guide 1.8 Biopsy UI

Model 55980-01 · Brainlab SE · DI 04056481094713

HAW — Neurological Stereotaxic Instrument · Class II · 21 CFR 882.4560

UDILibrary device dossier · generated 2026-09-06 · 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.

81725332019-01: 0 reports for this device; peer average 12.92/device2019-02: 0 reports for this device; peer average 14.35/device2019-03: 0 reports for this device; peer average 14.05/device2019-04: 0 reports for this device; peer average 18.63/device2019-05: 0 reports for this device; peer average 19.54/device2019-06: 0 reports for this device; peer average 20.19/device2019-07: 0 reports for this device; peer average 13.37/device2019-08: 0 reports for this device; peer average 11.15/device2019-09: 0 reports for this device; peer average 11.95/device2019-10: 0 reports for this device; peer average 9.58/device2019-11: 0 reports for this device; peer average 11.88/device2019-12: 0 reports for this device; peer average 14.46/device2020-01: 0 reports for this device; peer average 11.27/device2020-02: 0 reports for this device; peer average 12.22/device2020-03: 0 reports for this device; peer average 12.88/device2020-04: 0 reports for this device; peer average 10.44/device2020-05: 0 reports for this device; peer average 15.5/device2020-06: 0 reports for this device; peer average 12.21/device2020-07: 0 reports for this device; peer average 14.34/device2020-08: 0 reports for this device; peer average 12.98/device2020-09: 0 reports for this device; peer average 12.31/device2020-10: 0 reports for this device; peer average 12.61/device2020-11: 0 reports for this device; peer average 14.12/device2020-12: 0 reports for this device; peer average 12.64/device2021-01: 0 reports for this device; peer average 11.89/device2021-02: 0 reports for this device; peer average 14.14/device2021-03: 0 reports for this device; peer average 13.25/device2021-04: 0 reports for this device; peer average 13.21/device2021-05: 0 reports for this device; peer average 14.8/device2021-06: 0 reports for this device; peer average 18.26/device2021-07: 0 reports for this device; peer average 13.79/device2021-08: 0 reports for this device; peer average 17.29/device2021-09: 0 reports for this device; peer average 24.68/device2021-10: 0 reports for this device; peer average 14.32/device2021-11: 0 reports for this device; peer average 16.72/device2021-12: 0 reports for this device; peer average 12.67/device2022-01: 0 reports for this device; peer average 10.59/device2022-02: 0 reports for this device; peer average 13.53/device2022-03: 0 reports for this device; peer average 15.09/device2022-04: 0 reports for this device; peer average 12.75/device2022-05: 0 reports for this device; peer average 16.55/device2022-06: 0 reports for this device; peer average 15.68/device2022-07: 0 reports for this device; peer average 12.74/device2022-08: 0 reports for this device; peer average 13.73/device2022-09: 0 reports for this device; peer average 15.67/device2022-10: 0 reports for this device; peer average 18.18/device2022-11: 0 reports for this device; peer average 16.94/device2022-12: 0 reports for this device; peer average 16.56/device2023-01: 0 reports for this device; peer average 14/device2023-02: 0 reports for this device; peer average 12.62/device2023-03: 0 reports for this device; peer average 16.68/device2023-04: 0 reports for this device; peer average 14.38/device2023-05: 0 reports for this device; peer average 16.67/device2023-06: 0 reports for this device; peer average 24.22/device2023-07: 0 reports for this device; peer average 25.39/device2023-08: 0 reports for this device; peer average 21.23/device2023-09: 0 reports for this device; peer average 17.03/device2023-10: 0 reports for this device; peer average 17.29/device2023-11: 0 reports for this device; peer average 18.43/device2023-12: 0 reports for this device; peer average 20.54/device2024-01: 0 reports for this device; peer average 25.65/device2024-02: 0 reports for this device; peer average 20.49/device2024-03: 0 reports for this device; peer average 21.69/device2024-04: 0 reports for this device; peer average 22.32/device2024-05: 0 reports for this device; peer average 18.44/device2024-06: 0 reports for this device; peer average 19.81/device2024-07: 0 reports for this device; peer average 23.6/device2024-08: 0 reports for this device; peer average 29.73/device2024-09: 0 reports for this device; peer average 22.75/device2024-10: 0 reports for this device; peer average 27.4/device2024-11: 0 reports for this device; peer average 14.37/device2024-12: 0 reports for this device; peer average 16.74/device2025-01: 0 reports for this device; peer average 16.27/device2025-02: 0 reports for this device; peer average 21.38/device2025-03: 0 reports for this device; peer average 25.24/device2025-04: 0 reports for this device; peer average 23.34/device2025-05: 0 reports for this device; peer average 20.44/device2025-06: 0 reports for this device; peer average 33.41/device2025-07: 0 reports for this device; peer average 20.35/device2025-08: 0 reports for this device; peer average 17.63/device2025-09: 0 reports for this device; peer average 19.99/device2025-10: 0 reports for this device; peer average 18.6/device2025-11: 0 reports for this device; peer average 16.83/device2025-12: 0 reports for this device; peer average 15.93/device2026-01: 0 reports for this device; peer average 17/device2026-02: 0 reports for this device; peer average 14.12/device2026-03: 0 reports for this device; peer average 15.06/device2026-04: 0 reports for this device; peer average 11.52/device2026-05: 0 reports for this device; peer average 11.51/device2026-06: 0 reports for this device; peer average 8.95/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01012.92
2019-02014.35
2019-03014.05
2019-04018.63
2019-05019.54
2019-06020.19
2019-07013.37
2019-08011.15
2019-09011.95
2019-1009.58
2019-11011.88
2019-12014.46
2020-01011.27
2020-02012.22
2020-03012.88
2020-04010.44
2020-05015.5
2020-06012.21
2020-07014.34
2020-08012.98
2020-09012.31
2020-10012.61
2020-11014.12
2020-12012.64
2021-01011.89
2021-02014.14
2021-03013.25
2021-04013.21
2021-05014.8
2021-06018.26
2021-07013.79
2021-08017.29
2021-09024.68
2021-10014.32
2021-11016.72
2021-12012.67
2022-01010.59
2022-02013.53
2022-03015.09
2022-04012.75
2022-05016.55
2022-06015.68
2022-07012.74
2022-08013.73
2022-09015.67
2022-10018.18
2022-11016.94
2022-12016.56
2023-01014
2023-02012.62
2023-03016.68
2023-04014.38
2023-05016.67
2023-06024.22
2023-07025.39
2023-08021.23
2023-09017.03
2023-10017.29
2023-11018.43
2023-12020.54
2024-01025.65
2024-02020.49
2024-03021.69
2024-04022.32
2024-05018.44
2024-06019.81
2024-07023.6
2024-08029.73
2024-09022.75
2024-10027.4
2024-11014.37
2024-12016.74
2025-01016.27
2025-02021.38
2025-03025.24
2025-04023.34
2025-05020.44
2025-06033.41
2025-07020.35
2025-08017.63
2025-09019.99
2025-10018.6
2025-11016.83
2025-12015.93
2026-01017
2026-02014.12
2026-03015.06
2026-04011.52
2026-05011.51
2026-0608.95
This device (reports/month)Average device in HAW (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K092467 — cites (transitively): K082060 (d1) — cited as predicate by K171661, K192579, K192703, K193307, K201752, K231897

K192703 — cites (transitively): K070106 (d1), K092467 (d1), K082060 (d2) — cited as predicate by K213989, K223288, K223864

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

Manufacturer compliance record — Brainlab SE

  • NAI 2025-02-20 Brainlab SE · 0 citations
  • NAI 2025-02-20 Brainlab SE · 0 citations
  • NAI 2016-02-25 Brainlab SE · 0 citations
  • NAI 2016-02-25 Brainlab SE · 0 citations
  • VAI 2013-06-21 Brainlab SE · 3 citations
  • VAI 2013-06-21 Brainlab SE · 3 citations
  • NAI 2011-05-27 Brainlab SE · 0 citations
  • NAI 2011-05-27 Brainlab SE · 0 citations