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MINILAP

Model IPN002697 · TELEFLEX INCORPORATED · DI 14026704582584

OCW — Endoscopic Tissue Approximation Device · Class II · 21 CFR 876.1500

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.

368112019-01: 0 reports for this device; peer average 4.33/device2019-02: 0 reports for this device; peer average 5.22/device2019-03: 0 reports for this device; peer average 5.13/device2019-04: 0 reports for this device; peer average 5.93/device2019-05: 0 reports for this device; peer average 5.62/device2019-06: 0 reports for this device; peer average 4.83/device2019-07: 0 reports for this device; peer average 5.82/device2019-08: 0 reports for this device; peer average 3.1/device2019-09: 0 reports for this device; peer average 3.7/device2019-10: 0 reports for this device; peer average 4.36/device2019-11: 0 reports for this device; peer average 3.78/device2019-12: 0 reports for this device; peer average 5.45/device2020-01: 0 reports for this device; peer average 4.56/device2020-02: 0 reports for this device; peer average 2.78/device2020-03: 0 reports for this device; peer average 4.5/device2020-04: 0 reports for this device; peer average 3.1/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2.44/device2020-07: 0 reports for this device; peer average 3.77/device2020-08: 0 reports for this device; peer average 2.3/device2020-09: 0 reports for this device; peer average 4.22/device2020-10: 0 reports for this device; peer average 4.55/device2020-11: 0 reports for this device; peer average 4.6/device2020-12: 0 reports for this device; peer average 3.54/device2021-01: 0 reports for this device; peer average 3.67/device2021-02: 0 reports for this device; peer average 3.25/device2021-03: 0 reports for this device; peer average 4/device2021-04: 0 reports for this device; peer average 3.77/device2021-05: 0 reports for this device; peer average 2.92/device2021-06: 0 reports for this device; peer average 4.33/device2021-07: 0 reports for this device; peer average 2.92/device2021-08: 0 reports for this device; peer average 4.17/device2021-09: 0 reports for this device; peer average 3.43/device2021-10: 0 reports for this device; peer average 2.91/device2021-11: 0 reports for this device; peer average 3.36/device2021-12: 0 reports for this device; peer average 3.75/device2022-01: 0 reports for this device; peer average 4/device2022-02: 0 reports for this device; peer average 4.33/device2022-03: 0 reports for this device; peer average 3.4/device2022-04: 0 reports for this device; peer average 3.27/device2022-05: 0 reports for this device; peer average 6.4/device2022-06: 0 reports for this device; peer average 6.67/device2022-07: 0 reports for this device; peer average 5/device2022-08: 0 reports for this device; peer average 4.67/device2022-09: 0 reports for this device; peer average 2.93/device2022-10: 0 reports for this device; peer average 3.82/device2022-11: 0 reports for this device; peer average 3.18/device2022-12: 0 reports for this device; peer average 2.83/device2023-01: 0 reports for this device; peer average 3.67/device2023-02: 0 reports for this device; peer average 3.5/device2023-03: 0 reports for this device; peer average 3.69/device2023-04: 0 reports for this device; peer average 3.55/device2023-05: 0 reports for this device; peer average 3.39/device2023-06: 0 reports for this device; peer average 2.68/device2023-07: 0 reports for this device; peer average 3.75/device2023-08: 0 reports for this device; peer average 3.25/device2023-09: 0 reports for this device; peer average 3.07/device2023-10: 0 reports for this device; peer average 5.38/device2023-11: 0 reports for this device; peer average 3.22/device2023-12: 0 reports for this device; peer average 4.73/device2024-01: 0 reports for this device; peer average 4.55/device2024-02: 0 reports for this device; peer average 3.22/device2024-03: 0 reports for this device; peer average 2.73/device2024-04: 0 reports for this device; peer average 3.75/device2024-05: 0 reports for this device; peer average 2.14/device2024-06: 0 reports for this device; peer average 3.54/device2024-07: 0 reports for this device; peer average 2.58/device2024-08: 0 reports for this device; peer average 2.71/device2024-09: 0 reports for this device; peer average 3.21/device2024-10: 0 reports for this device; peer average 3.6/device2024-11: 0 reports for this device; peer average 3.43/device2024-12: 0 reports for this device; peer average 1.8/device2025-01: 0 reports for this device; peer average 5/device2025-02: 0 reports for this device; peer average 4.15/device2025-03: 0 reports for this device; peer average 4.33/device2025-04: 0 reports for this device; peer average 4.22/device2025-05: 0 reports for this device; peer average 4.45/device2025-06: 0 reports for this device; peer average 4.65/device2025-07: 0 reports for this device; peer average 5.56/device2025-08: 0 reports for this device; peer average 4.33/device2025-09: 0 reports for this device; peer average 2.5/device2025-10: 0 reports for this device; peer average 3.13/device2025-11: 0 reports for this device; peer average 4.64/device2025-12: 0 reports for this device; peer average 6.5/device2026-01: 0 reports for this device; peer average 4.29/device2026-02: 0 reports for this device; peer average 4.42/device2026-03: 0 reports for this device; peer average 5.57/device2026-04: 0 reports for this device; peer average 7.07/device2026-05: 0 reports for this device; peer average 11.14/device2026-06: 0 reports for this device; peer average 7.69/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.33
2019-0205.22
2019-0305.13
2019-0405.93
2019-0505.62
2019-0604.83
2019-0705.82
2019-0803.1
2019-0903.7
2019-1004.36
2019-1103.78
2019-1205.45
2020-0104.56
2020-0202.78
2020-0304.5
2020-0403.1
2020-0502
2020-0602.44
2020-0703.77
2020-0802.3
2020-0904.22
2020-1004.55
2020-1104.6
2020-1203.54
2021-0103.67
2021-0203.25
2021-0304
2021-0403.77
2021-0502.92
2021-0604.33
2021-0702.92
2021-0804.17
2021-0903.43
2021-1002.91
2021-1103.36
2021-1203.75
2022-0104
2022-0204.33
2022-0303.4
2022-0403.27
2022-0506.4
2022-0606.67
2022-0705
2022-0804.67
2022-0902.93
2022-1003.82
2022-1103.18
2022-1202.83
2023-0103.67
2023-0203.5
2023-0303.69
2023-0403.55
2023-0503.39
2023-0602.68
2023-0703.75
2023-0803.25
2023-0903.07
2023-1005.38
2023-1103.22
2023-1204.73
2024-0104.55
2024-0203.22
2024-0302.73
2024-0403.75
2024-0502.14
2024-0603.54
2024-0702.58
2024-0802.71
2024-0903.21
2024-1003.6
2024-1103.43
2024-1201.8
2025-0105
2025-0204.15
2025-0304.33
2025-0404.22
2025-0504.45
2025-0604.65
2025-0705.56
2025-0804.33
2025-0902.5
2025-1003.13
2025-1104.64
2025-1206.5
2026-0104.29
2026-0204.42
2026-0305.57
2026-0407.07
2026-05011.14
2026-0607.69
This device (reports/month)Average device in OCW (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K070686 — cited as predicate by K093449, K113597, K132232, K160149, K172775

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

Manufacturer compliance record — TELEFLEX INCORPORATED

  • NAI 2026-01-15 Teleflex Medical OEM LLC · 0 citations
  • NAI 2024-03-18 Teleflex LLC (NADC) · 0 citations
  • NAI 2024-03-18 Teleflex LLC (NADC) · 0 citations
  • NAI 2024-01-26 Teleflex Medical OEM LLC · 0 citations
  • NAI 2022-12-09 Teleflex Medical de Tecate, S. de R.L de C.V. (A Teleflex Medical Company) · 0 citations
  • VAI 2022-08-26 TELEFLEX LLC · 3 citations
  • VAI 2022-08-26 TELEFLEX LLC · 3 citations
  • NAI 2021-09-02 TELEFLEX LLC · 0 citations
  • NAI 2021-09-02 TELEFLEX LLC · 0 citations
  • VAI 2021-07-30 Teleflex LLC (NADC) · 4 citations
  • NAI 2017-09-21 Teleflex LLC · 0 citations
  • VAI 2017-09-20 Teleflex Medical, Inc. · 1 citations
  • NAI 2017-02-02 Teleflex Medical OEM LLC · 0 citations
  • NAI 2016-08-29 Teleflex Medical OEM LLC · 0 citations
  • NAI 2016-03-03 Teleflex LLC (NADC) · 0 citations
  • NAI 2016-03-03 Teleflex LLC (NADC) · 0 citations
  • NAI 2015-08-13 Teleflex Medical Sdn. Bhd. · 0 citations
  • NAI 2015-06-05 Teleflex Medical Europe Ltd · 0 citations
  • NAI 2015-02-25 Teleflex Medical Europe, Ltd. · 0 citations
  • NAI 2014-08-28 TELEFLEX LLC · 0 citations