Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

MyoSure Tissue Removal Device

Model 30-401LITE · Hologic, Inc. · DI 15420045505070

HIH — Hysteroscope (And Accessories) · Class II · 21 CFR 884.1690

UDILibrary device dossier · generated 2026-09-15 · 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 (251)

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.

Injury: 124 · Malfunction: 122 · Death: 4 · Other: 1

51015212019-01: 0 reports for this device; peer average 4/device2019-02: 0 reports for this device; peer average 2.58/device2019-03: 0 reports for this device; peer average 3.29/device2019-04: 5 reports for this device; peer average 4/device2019-05: 2 reports for this device; peer average 2.2/device2019-06: 5 reports for this device; peer average 5/device2019-07: 0 reports for this device; peer average 4.59/device2019-08: 0 reports for this device; peer average 3.42/device2019-09: 2 reports for this device; peer average 2.33/device2019-10: 4 reports for this device; peer average 3.5/device2019-11: 0 reports for this device; peer average 2.93/device2019-12: 3 reports for this device; peer average 4.27/device2020-01: 0 reports for this device; peer average 3.67/device2020-02: 2 reports for this device; peer average 4/device2020-03: 0 reports for this device; peer average 3.88/device2020-04: 5 reports for this device; peer average 3.27/device2020-05: 2 reports for this device; peer average 2.71/device2020-06: 0 reports for this device; peer average 5/device2020-07: 0 reports for this device; peer average 2.05/device2020-08: 0 reports for this device; peer average 2.67/device2020-09: 2 reports for this device; peer average 2.62/device2020-10: 0 reports for this device; peer average 4/device2020-11: 0 reports for this device; peer average 3.31/device2020-12: 8 reports for this device; peer average 4.33/device2021-01: 2 reports for this device; peer average 2.25/device2021-02: 0 reports for this device; peer average 4.14/device2021-03: 3 reports for this device; peer average 3.44/device2021-04: 5 reports for this device; peer average 3.8/device2021-05: 0 reports for this device; peer average 2.69/device2021-06: 0 reports for this device; peer average 6.18/device2021-07: 0 reports for this device; peer average 8/device2021-08: 5 reports for this device; peer average 4.26/device2021-09: 8 reports for this device; peer average 4.29/device2021-10: 2 reports for this device; peer average 5.75/device2021-11: 3 reports for this device; peer average 4.21/device2021-12: 8 reports for this device; peer average 5.58/device2022-01: 2 reports for this device; peer average 4.76/device2022-02: 0 reports for this device; peer average 3.06/device2022-03: 0 reports for this device; peer average 6.19/device2022-04: 2 reports for this device; peer average 4.15/device2022-05: 2 reports for this device; peer average 5/device2022-06: 2 reports for this device; peer average 2.13/device2022-07: 2 reports for this device; peer average 3.87/device2022-08: 0 reports for this device; peer average 3.42/device2022-09: 2 reports for this device; peer average 3.15/device2022-10: 1 reports for this device; peer average 3/device2022-11: 0 reports for this device; peer average 3.89/device2022-12: 2 reports for this device; peer average 11.2/device2023-01: 5 reports for this device; peer average 20.62/device2023-02: 2 reports for this device; peer average 9.35/device2023-03: 0 reports for this device; peer average 12.22/device2023-04: 3 reports for this device; peer average 13.21/device2023-05: 0 reports for this device; peer average 18.4/device2023-06: 0 reports for this device; peer average 18.95/device2023-07: 0 reports for this device; peer average 11.93/device2023-08: 6 reports for this device; peer average 11.5/device2023-09: 0 reports for this device; peer average 10.06/device2023-10: 14 reports for this device; peer average 10.82/device2023-11: 0 reports for this device; peer average 9.45/device2023-12: 3 reports for this device; peer average 11.69/device2024-01: 2 reports for this device; peer average 9.13/device2024-02: 13 reports for this device; peer average 11.61/device2024-03: 4 reports for this device; peer average 12.31/device2024-04: 3 reports for this device; peer average 10.69/device2024-05: 3 reports for this device; peer average 12.26/device2024-06: 7 reports for this device; peer average 9.57/device2024-07: 2 reports for this device; peer average 10.33/device2024-08: 0 reports for this device; peer average 11.61/device2024-09: 2 reports for this device; peer average 13.31/device2024-10: 4 reports for this device; peer average 10.49/device2024-11: 16 reports for this device; peer average 8.09/device2024-12: 3 reports for this device; peer average 12.53/device2025-01: 0 reports for this device; peer average 11.32/device2025-02: 0 reports for this device; peer average 12.94/device2025-03: 6 reports for this device; peer average 9.6/device2025-04: 5 reports for this device; peer average 10.36/device2025-05: 0 reports for this device; peer average 9.76/device2025-06: 6 reports for this device; peer average 9.05/device2025-07: 0 reports for this device; peer average 9.3/device2025-08: 3 reports for this device; peer average 9.82/device2025-09: 7 reports for this device; peer average 9.47/device2025-10: 3 reports for this device; peer average 8.89/device2025-11: 9 reports for this device; peer average 9.82/device2025-12: 0 reports for this device; peer average 9.93/device2026-01: 3 reports for this device; peer average 12.47/device2026-02: 3 reports for this device; peer average 17.64/device2026-03: 0 reports for this device; peer average 8.42/device2026-04: 6 reports for this device; peer average 8.76/device2026-05: 3 reports for this device; peer average 6.15/device2026-06: 14 reports for this device; peer average 8.38/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104
2019-0202.58
2019-0303.29
2019-0454
2019-0522.2
2019-0655
2019-0704.59
2019-0803.42
2019-0922.33
2019-1043.5
2019-1102.93
2019-1234.27
2020-0103.67
2020-0224
2020-0303.88
2020-0453.27
2020-0522.71
2020-0605
2020-0702.05
2020-0802.67
2020-0922.62
2020-1004
2020-1103.31
2020-1284.33
2021-0122.25
2021-0204.14
2021-0333.44
2021-0453.8
2021-0502.69
2021-0606.18
2021-0708
2021-0854.26
2021-0984.29
2021-1025.75
2021-1134.21
2021-1285.58
2022-0124.76
2022-0203.06
2022-0306.19
2022-0424.15
2022-0525
2022-0622.13
2022-0723.87
2022-0803.42
2022-0923.15
2022-1013
2022-1103.89
2022-12211.2
2023-01520.62
2023-0229.35
2023-03012.22
2023-04313.21
2023-05018.4
2023-06018.95
2023-07011.93
2023-08611.5
2023-09010.06
2023-101410.82
2023-1109.45
2023-12311.69
2024-0129.13
2024-021311.61
2024-03412.31
2024-04310.69
2024-05312.26
2024-0679.57
2024-07210.33
2024-08011.61
2024-09213.31
2024-10410.49
2024-11168.09
2024-12312.53
2025-01011.32
2025-02012.94
2025-0369.6
2025-04510.36
2025-0509.76
2025-0669.05
2025-0709.3
2025-0839.82
2025-0979.47
2025-1038.89
2025-1199.82
2025-1209.93
2026-01312.47
2026-02317.64
2026-0308.42
2026-0468.76
2026-0536.15
2026-06148.38
This device (reports/month)Average device in HIH (reports/device/month)

Regulatory clearances

  • K142029 SESE 2014-11-26 (k number procode)

Predicate lineage

K142029 — cites (transitively): K132015 (d1) — cited as predicate by K152723, K170120, K173901

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

Manufacturer compliance record — Hologic, Inc.

  • Warning Letter 2024-12-18 Hologic, Inc
  • Warning Letter 2024-12-18 Hologic, Inc
  • OAI 2025-11-04 Hologic, Inc · 3 citations
  • OAI 2025-11-04 Hologic, Inc · 3 citations
  • OAI 2024-09-24 Hologic, Inc · 5 citations
  • OAI 2024-09-24 Hologic, Inc · 5 citations
  • VAI 2024-09-12 Hologic Surgical Products Costa Rica, S.R.L. · 0 citations
  • NAI 2024-08-13 Hologic, Inc. · 0 citations
  • NAI 2024-08-13 Hologic, Inc. · 0 citations
  • NAI 2022-12-14 Bolder Surgical, LLC · 0 citations
  • OAI 2022-10-14 Hologic, Inc. · 4 citations
  • OAI 2022-10-14 Hologic, Inc. · 4 citations
  • VAI 2022-08-03 Health Beacons, Inc. · 1 citations
  • NAI 2020-02-25 Health Beacons, Inc. · 0 citations
  • NAI 2018-12-10 Hologic, Inc. · 0 citations
  • NAI 2018-12-10 Hologic, Inc. · 0 citations
  • NAI 2018-02-27 Gynesonics, Inc. · 0 citations
  • NAI 2017-11-30 Hologic, Inc · 0 citations
  • NAI 2017-11-30 Hologic, Inc · 0 citations
  • VAI 2017-11-27 Bolder Surgical, LLC · 6 citations
  • NAI 2017-10-25 Hologic, Inc. · 0 citations
  • NAI 2017-10-25 Hologic, Inc. · 0 citations