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Berkeley Vacurette

Model 20317 · Gyrus ACMI, LLC · DI 00821925037465

HHK — Curette, Suction, Endometrial (And Accessories) · Class II · 21 CFR 884.1175

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.

358102019-11: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 10/device2025-07: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 4/device11071002030608120203010203040810010507090104
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-1101
2021-0701
2021-1001
2022-0201
2022-0301
2022-0601
2022-0802
2022-1201
2023-0202
2023-0301
2024-0102
2024-0202
2024-0302
2024-0401
2024-0801
2024-1001
2025-0101
2025-05010
2025-0702
2025-0901
2026-0102
2026-0404
This device (reports/month)Average device in HHK (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Gyrus ACMI, LLC

  • VAI 2023-11-02 Gyrus ACMI, Inc. · 3 citations
  • NAI 2022-05-02 Gyrus ACMI, Inc. · 0 citations
  • NAI 2020-01-14 Gyrus ACMI, Inc. · 0 citations
  • NAI 2018-05-23 Gyrus ACMI, Inc. · 0 citations
  • VAI 2018-04-17 Gyrus ACMI, Inc. · 1 citations
  • NAI 2017-07-27 Gyrus ACMI, Inc. · 0 citations
  • NAI 2016-08-17 Gyrus ACMI, Inc. · 0 citations
  • NAI 2016-07-01 Gyrus ACMI, Inc. · 0 citations
  • NAI 2015-12-11 Gyrus ACMI, Inc. · 0 citations
  • VAI 2015-04-03 Gyrus ACMI, Inc. · 1 citations
  • NAI 2015-03-20 Gyrus ACMI, Inc. · 0 citations
  • VAI 2013-09-18 Gyrus ACMI, Inc. · 4 citations
  • VAI 2013-06-21 Gyrus ACMI, Inc. · 1 citations
  • VAI 2013-06-11 Gyrus Acmi, Inc. · 2 citations
  • NAI 2012-08-31 Gyrus ACMI, Inc. · 0 citations
  • VAI 2012-06-14 Gyrus ACMI, Inc. · 2 citations
  • NAI 2011-06-13 Gyrus ACMI, Inc. · 0 citations
  • NAI 2010-09-15 Gyrus ACMI, Inc. · 0 citations
  • NAI 2010-06-24 Gyrus Acmi, Inc. · 0 citations