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Acessa ProVu System

Model 7100 · Hologic, Inc. · DI 15420045515307

HFG — Coagulator, Laparoscopic, Unipolar (And Accessories) · Class II · 21 CFR 884.4160

UDILibrary device dossier · generated 2026-09-16 · 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 (25)

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.

Malfunction: 16 · Injury: 8 · Death: 1

358102019-06: 0 reports for this device; peer average 3/device2019-07: 0 reports for this device; peer average 4/device2020-01: 0 reports for this device; peer average 5/device2020-05: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 1.5/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 5/device2021-10: 0 reports for this device; peer average 2/device2021-11: 1 reports for this device; peer average 2.5/device2021-12: 0 reports for this device; peer average 10/device2022-01: 0 reports for this device; peer average 5/device2022-03: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 2.5/device2022-08: 0 reports for this device; peer average 3/device2022-09: 2 reports for this device; peer average 1.67/device2022-10: 0 reports for this device; peer average 2.67/device2022-11: 1 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 2/device2023-01: 1 reports for this device; peer average 2.5/device2023-02: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 8/device2023-05: 2 reports for this device; peer average 3.2/device2023-06: 0 reports for this device; peer average 1.5/device2023-07: 2 reports for this device; peer average 3/device2023-08: 0 reports for this device; peer average 4/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 6/device2023-11: 0 reports for this device; peer average 3/device2023-12: 3 reports for this device; peer average 2.5/device2024-01: 0 reports for this device; peer average 3/device2024-02: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 4/device2024-09: 0 reports for this device; peer average 3/device2024-10: 0 reports for this device; peer average 9/device2024-11: 2 reports for this device; peer average 1.5/device2024-12: 0 reports for this device; peer average 2.5/device2025-01: 0 reports for this device; peer average 3/device2025-02: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 1.5/device2025-04: 0 reports for this device; peer average 4/device2025-05: 0 reports for this device; peer average 1.67/device2025-06: 0 reports for this device; peer average 3/device2025-07: 4 reports for this device; peer average 7/device2025-08: 0 reports for this device; peer average 7.5/device2025-09: 1 reports for this device; peer average 5/device2025-10: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 3/device2025-12: 1 reports for this device; peer average 2/device2026-01: 3 reports for this device; peer average 6/device2026-02: 2 reports for this device; peer average 3/device2026-03: 0 reports for this device; peer average 3/device2026-04: 0 reports for this device; peer average 3/device2026-05: 0 reports for this device; peer average 4.5/device2026-06: 0 reports for this device; peer average 4.5/device0607010510070809101112010304070809101112010203040506070809101112010204050609101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0603
2019-0704
2020-0105
2020-0502
2020-1002
2021-0701.5
2021-0802
2021-0905
2021-1002
2021-1112.5
2021-12010
2022-0105
2022-0302
2022-0402
2022-0702.5
2022-0803
2022-0921.67
2022-1002.67
2022-1111
2022-1202
2023-0112.5
2023-0203
2023-0302
2023-0408
2023-0523.2
2023-0601.5
2023-0723
2023-0804
2023-0902
2023-1006
2023-1103
2023-1232.5
2024-0103
2024-0202
2024-0401
2024-0501
2024-0604
2024-0903
2024-1009
2024-1121.5
2024-1202.5
2025-0103
2025-0202
2025-0301.5
2025-0404
2025-0501.67
2025-0603
2025-0747
2025-0807.5
2025-0915
2025-1002
2025-1103
2025-1212
2026-0136
2026-0223
2026-0303
2026-0403
2026-0504.5
2026-0604.5
This device (reports/month)Average device in HFG (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

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