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

ABBI

Model ABBI-KIT · Coopersurgical, Inc. · DI 60888937014183

LKF — Cannula, Manipulator/Injector, Uterine · Class II · 21 CFR 884.4530

UDILibrary device dossier · generated 2026-09-06 · 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.

4812162019-01: 0 reports for this device; peer average 2/device2019-02: 0 reports for this device; peer average 1.8/device2019-03: 0 reports for this device; peer average 4.33/device2019-04: 0 reports for this device; peer average 4.33/device2019-05: 0 reports for this device; peer average 4.67/device2019-06: 0 reports for this device; peer average 3.5/device2019-07: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 3.67/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 3.5/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1.67/device2020-01: 0 reports for this device; peer average 2.4/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 3.8/device2020-04: 0 reports for this device; peer average 2.83/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 4.5/device2020-07: 0 reports for this device; peer average 4/device2020-08: 0 reports for this device; peer average 1.71/device2020-09: 0 reports for this device; peer average 3.75/device2020-10: 0 reports for this device; peer average 4/device2020-11: 0 reports for this device; peer average 7/device2020-12: 0 reports for this device; peer average 2.17/device2021-01: 0 reports for this device; peer average 2.2/device2021-02: 0 reports for this device; peer average 4/device2021-03: 0 reports for this device; peer average 4.5/device2021-04: 0 reports for this device; peer average 3.6/device2021-05: 0 reports for this device; peer average 3.17/device2021-06: 0 reports for this device; peer average 6/device2021-07: 0 reports for this device; peer average 13/device2021-08: 0 reports for this device; peer average 4.25/device2021-09: 0 reports for this device; peer average 6/device2021-10: 0 reports for this device; peer average 1.67/device2021-11: 0 reports for this device; peer average 3.5/device2021-12: 0 reports for this device; peer average 7.5/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 2.5/device2022-03: 0 reports for this device; peer average 4.25/device2022-04: 0 reports for this device; peer average 2.75/device2022-05: 0 reports for this device; peer average 2.67/device2022-06: 0 reports for this device; peer average 2.5/device2022-07: 0 reports for this device; peer average 4.33/device2022-08: 0 reports for this device; peer average 2.25/device2022-09: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 2.5/device2022-11: 0 reports for this device; peer average 2.67/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 6.5/device2023-02: 0 reports for this device; peer average 1.8/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 1.5/device2023-05: 0 reports for this device; peer average 7.5/device2023-06: 0 reports for this device; peer average 1.75/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1.8/device2023-09: 0 reports for this device; peer average 1.33/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 2.33/device2023-12: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 4/device2024-02: 0 reports for this device; peer average 2.83/device2024-03: 0 reports for this device; peer average 1.67/device2024-04: 0 reports for this device; peer average 3.33/device2024-05: 0 reports for this device; peer average 1.67/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 2.75/device2024-08: 0 reports for this device; peer average 4.33/device2024-09: 0 reports for this device; peer average 8/device2024-10: 0 reports for this device; peer average 3/device2024-11: 0 reports for this device; peer average 3.33/device2024-12: 0 reports for this device; peer average 3/device2025-01: 0 reports for this device; peer average 4.33/device2025-02: 0 reports for this device; peer average 3.67/device2025-03: 0 reports for this device; peer average 1.5/device2025-04: 0 reports for this device; peer average 3/device2025-05: 0 reports for this device; peer average 3/device2025-06: 0 reports for this device; peer average 2.67/device2025-07: 0 reports for this device; peer average 3/device2025-08: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 2.67/device2025-11: 0 reports for this device; peer average 3.67/device2025-12: 0 reports for this device; peer average 2.25/device2026-01: 0 reports for this device; peer average 3.67/device2026-02: 0 reports for this device; peer average 3/device2026-03: 0 reports for this device; peer average 3.5/device2026-04: 0 reports for this device; peer average 2.5/device2026-05: 0 reports for this device; peer average 16/device2026-06: 0 reports for this device; peer average 3.33/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0201.8
2019-0304.33
2019-0404.33
2019-0504.67
2019-0603.5
2019-0702
2019-0803.67
2019-0902
2019-1003.5
2019-1101
2019-1201.67
2020-0102.4
2020-0202
2020-0303.8
2020-0402.83
2020-0501
2020-0604.5
2020-0704
2020-0801.71
2020-0903.75
2020-1004
2020-1107
2020-1202.17
2021-0102.2
2021-0204
2021-0304.5
2021-0403.6
2021-0503.17
2021-0606
2021-07013
2021-0804.25
2021-0906
2021-1001.67
2021-1103.5
2021-1207.5
2022-0101
2022-0202.5
2022-0304.25
2022-0402.75
2022-0502.67
2022-0602.5
2022-0704.33
2022-0802.25
2022-0902
2022-1002.5
2022-1102.67
2022-1202
2023-0106.5
2023-0201.8
2023-0302
2023-0401.5
2023-0507.5
2023-0601.75
2023-0702
2023-0801.8
2023-0901.33
2023-1002
2023-1102.33
2023-1202
2024-0104
2024-0202.83
2024-0301.67
2024-0403.33
2024-0501.67
2024-0601
2024-0702.75
2024-0804.33
2024-0908
2024-1003
2024-1103.33
2024-1203
2025-0104.33
2025-0203.67
2025-0301.5
2025-0403
2025-0503
2025-0602.67
2025-0703
2025-0801
2025-0902
2025-1002.67
2025-1103.67
2025-1202.25
2026-0103.67
2026-0203
2026-0303.5
2026-0402.5
2026-05016
2026-0603.33
This device (reports/month)Average device in LKF (reports/device/month)

Regulatory clearances

  • K143415 SESE 2015-02-26 (k number procode)

Predicate lineage

K143415 — cites (transitively): K013972 (d1), K110288 (d1), K020954 (d2)

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

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