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Advincula Delineator Uterine Manipulator

Model AD750SC-KE35 · Coopersurgical, Inc. · DI 00888937021363

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

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (2)

InitiatedRecall #ClassStatusReasonLink basis
2019-06-14Z-1977-2019Class IITerminatedThe soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations.k number procode
2019-06-14Z-1978-2019Class IITerminatedThe soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations.k number procode

Adverse-event reports — MAUDE (8)

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: 8

24572019-01: 1 reports for this device; peer average 1/device2019-02: 1 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: 1 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: 1 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 3/device2020-09: 1 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: 1 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2021-12: 1 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: 1 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)
2019-0111
2019-0211.5
2019-0301.8
2019-0401
2019-0501
2019-0611
2019-0701
2019-0801
2019-0901
2019-1001.5
2019-1101
2020-0501.5
2020-0602.5
2020-0711
2020-0803
2020-0911.33
2020-1001.17
2020-1101
2020-1201.33
2021-0104
2021-0201
2021-0501.33
2021-0601
2021-1011
2021-1101
2021-1211.33
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
2024-0212
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

  • K180429 SESE 2018-03-14 (k number procode)

Predicate lineage

K180429 — cites (transitively): K143650 (d1), K954311 (d2) — cited as predicate by K201086

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