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Acessa ProVu Dual Foot Pedal

Model MS-06-0171 · ACESSA HEALTH INC. · DI 00854763006256

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

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 (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.

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: 0 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: 0 reports for this device; peer average 1.67/device2022-10: 0 reports for this device; peer average 2.67/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 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: 0 reports for this device; peer average 3.2/device2023-06: 0 reports for this device; peer average 1.5/device2023-07: 0 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: 0 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: 0 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: 0 reports for this device; peer average 7/device2025-08: 0 reports for this device; peer average 7.5/device2025-09: 0 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: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 6/device2026-02: 0 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
2021-1102.5
2021-12010
2022-0105
2022-0302
2022-0402
2022-0702.5
2022-0803
2022-0901.67
2022-1002.67
2022-1101
2022-1202
2023-0102.5
2023-0203
2023-0302
2023-0408
2023-0503.2
2023-0601.5
2023-0703
2023-0804
2023-0902
2023-1006
2023-1103
2023-1202.5
2024-0103
2024-0202
2024-0401
2024-0501
2024-0604
2024-0903
2024-1009
2024-1101.5
2024-1202.5
2025-0103
2025-0202
2025-0301.5
2025-0404
2025-0501.67
2025-0603
2025-0707
2025-0807.5
2025-0905
2025-1002
2025-1103
2025-1202
2026-0106
2026-0203
2026-0303
2026-0403
2026-0504.5
2026-0604.5
This device (reports/month)Average device in HFG (reports/device/month)

Regulatory clearances

  • K181124 SESE 2018-09-28 (k number procode)

Predicate lineage

K181124 — cites (transitively): K040719 (d1), K093488 (d1), K121858 (d1), K132744 (d1), K163121 (d1), K094009 (d2), K121479 (d2), K112646 (d2), K113184 (d2), K993944 (d3), K093714 (d3), K102065 (d3), K103722 (d3), K100186 (d3), K083728 (d3), K061213 (d4), K063580 (d4), K101829 (d4)

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

Manufacturer compliance record — ACESSA HEALTH INC.

  • NAI 2018-04-18 Acessa Health Inc. · 0 citations
  • NAI 2014-11-03 Acessa Health Inc. · 0 citations
  • NAI 2012-02-17 Acessa Health Inc. · 0 citations