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Advincula Delineator™ Uterine Manipulator with 3.0 cm Stainless Steel Koh-Effici

Model AD750-KES30 · Coopersurgical, Inc. · DI 00888937012774

HEW — Culdoscope (And Accessories) · Class II · 21 CFR 884.1640

UDILibrary device dossier · generated 2026-09-12 · 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.

24572019-01: 0 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1.5/device2019-03: 0 reports for this device; peer average 1.8/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1.5/device2019-11: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1.5/device2020-06: 0 reports for this device; peer average 2.5/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 3/device2020-09: 0 reports for this device; peer average 1.33/device2020-10: 0 reports for this device; peer average 1.17/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1.33/device2021-01: 0 reports for this device; peer average 4/device2021-02: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1.33/device2021-06: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1.33/device2022-01: 0 reports for this device; peer average 1.5/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1.67/device2022-04: 0 reports for this device; peer average 1.67/device2022-06: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 2.5/device2023-08: 0 reports for this device; peer average 2/device2023-09: 0 reports for this device; peer average 1.5/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 1/device2023-12: 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 1/device2024-04: 0 reports for this device; peer average 1.5/device2024-07: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 4.33/device2024-09: 0 reports for this device; peer average 6/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 4/device2025-01: 0 reports for this device; peer average 3/device2025-02: 0 reports for this device; peer average 3/device2025-03: 0 reports for this device; peer average 6/device2025-04: 0 reports for this device; peer average 7/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 2.5/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 5/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 3/device2026-04: 0 reports for this device; peer average 2.25/device2026-05: 0 reports for this device; peer average 2.33/device2026-06: 0 reports for this device; peer average 2/device010203040506070809101105060708091011120102050610111201020304060708091011120103060708091011120203040708091011120102030406071112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0201.5
2019-0301.8
2019-0401
2019-0501
2019-0601
2019-0701
2019-0801
2019-0901
2019-1001.5
2019-1101
2020-0501.5
2020-0602.5
2020-0701
2020-0803
2020-0901.33
2020-1001.17
2020-1101
2020-1201.33
2021-0104
2021-0201
2021-0501.33
2021-0601
2021-1001
2021-1101
2021-1201.33
2022-0101.5
2022-0201
2022-0301.67
2022-0401.67
2022-0601
2022-0702
2022-0801
2022-0902
2022-1002
2022-1101
2022-1201
2023-0102
2023-0303
2023-0602
2023-0702.5
2023-0802
2023-0901.5
2023-1002
2023-1101
2023-1202
2024-0202
2024-0301
2024-0401.5
2024-0702
2024-0804.33
2024-0906
2024-1002
2024-1102
2024-1204
2025-0103
2025-0203
2025-0306
2025-0407
2025-0602
2025-0701
2025-1102.5
2025-1202
2026-0105
2026-0202
2026-0303
2026-0402.25
2026-0502.33
2026-0602
This device (reports/month)Average device in HEW (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Coopersurgical, Inc.

  • Warning Letter 2015-06-09 CooperSurgical, Inc.
  • Warning Letter 2015-06-09 CooperSurgical, Inc.
  • Warning Letter 2013-04-25 Lone Star Medical Products, Inc.
  • Warning Letter 2012-07-11 Leisegang Feinmechanick-Optik GmbH
  • VAI 2024-02-01 CooperSurgical, Inc. · 0 citations
  • NAI 2023-05-16 CooperSurgical, Inc. · 0 citations
  • NAI 2023-05-16 CooperSurgical, Inc. · 0 citations
  • VAI 2023-04-27 Lone Star Medical Products, Inc. · 5 citations
  • NAI 2022-12-15 Leisegang Feinmechanick-Optik GmbH · 0 citations
  • VAI 2021-07-15 CooperSurgical, Inc. · 4 citations
  • VAI 2021-07-15 CooperSurgical, Inc. · 4 citations
  • NAI 2019-08-01 CooperSurgical, Inc. · 2 citations
  • NAI 2018-05-02 Lone Star Medical Products, Inc. · 0 citations
  • NAI 2017-12-07 CooperSurgical, Inc. · 0 citations
  • NAI 2017-12-07 CooperSurgical, Inc. · 0 citations
  • NAI 2017-05-04 Lone Star Medical Products, Inc. · 0 citations
  • NAI 2016-03-31 CooperSurgical, Inc. · 0 citations
  • NAI 2016-03-31 CooperSurgical, Inc. · 0 citations
  • NAI 2015-12-10 Leisegang Feinmechanick-Optik GmbH · 0 citations
  • OAI 2014-12-17 CooperSurgical, Inc. · 8 citations
  • OAI 2014-12-17 CooperSurgical, Inc. · 8 citations
  • NAI 2014-12-01 CooperSurgical, Inc. · 0 citations
  • NAI 2014-12-01 CooperSurgical, Inc. · 0 citations
  • VAI 2014-09-23 Lone Star Medical Products, Inc. · 0 citations