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Stealth Autoguide™ System

Model 28336 · MEDTRONIC NAVIGATION, INC. · DI 00763000215873

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

UDILibrary device dossier · generated 2026-09-07 · 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

K191597 — cites (transitively): K131433 (d1), K151359 (d1), K162309 (d1), K162604 (d1), K163182 (d1), K170312 (d1), K101791 (d2), K101797 (d2), K050438 (d2), K133444 (d2), K153660 (d2), K012366 (d2), K992304 (d2), K020069 (d2), K072315 (d2), K090112 (d2), K870157 (d2), K012457 (d2), K081475 (d2), K121264 (d2), K001801 (d3), K023651 (d3), K092239 (d3), K991081 (d3), K002906 (d3), K042777 (d3), K060245 (d3), K081277 (d3), K150216 (d3), K992927 (d3) — cited as predicate by K203720, K210989, K213454, K223864, K243698

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

Manufacturer compliance record — MEDTRONIC NAVIGATION, INC.

  • Warning Letter 2010-05-07 Medtronic Navigation, Inc.
  • VAI 2024-02-09 Medtronic Navigation, Inc. · 3 citations
  • VAI 2021-06-29 Medtronic Navigation, Inc. · 3 citations
  • VAI 2019-09-30 Medtronic Navigation, Inc. · 1 citations
  • VAI 2016-08-18 Medtronic Navigation, Inc. · 0 citations
  • NAI 2014-12-15 Medtronic Navigation, Inc. · 0 citations
  • VAI 2014-02-19 Medtronic Navigation, Inc. · 5 citations
  • NAI 2012-09-06 Medtronic Navigation, Inc. · 0 citations
  • NAI 2012-05-01 Medtronic Navigation, Inc. · 0 citations
  • VAI 2011-03-24 Medtronic Navigation, Inc. · 1 citations
  • OAI 2010-02-04 Medtronic Navigation, Inc. · 9 citations