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Model IPN033815 · TELEFLEX INCORPORATED · DI 10816000012434

FCG — Biopsy Needle · Class II · 21 CFR 876.1075

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.

24692019-01: 0 reports for this device; peer average 2.43/device2019-02: 0 reports for this device; peer average 5.57/device2019-03: 0 reports for this device; peer average 3.31/device2019-04: 0 reports for this device; peer average 3.13/device2019-05: 0 reports for this device; peer average 3.18/device2019-06: 0 reports for this device; peer average 4.4/device2019-07: 0 reports for this device; peer average 4.12/device2019-08: 0 reports for this device; peer average 4.31/device2019-09: 0 reports for this device; peer average 3/device2019-10: 0 reports for this device; peer average 3.18/device2019-11: 0 reports for this device; peer average 2.79/device2019-12: 0 reports for this device; peer average 2.76/device2020-01: 0 reports for this device; peer average 3/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 1.95/device2020-04: 0 reports for this device; peer average 1.58/device2020-05: 0 reports for this device; peer average 1.59/device2020-06: 0 reports for this device; peer average 1.36/device2020-07: 0 reports for this device; peer average 1.66/device2020-08: 0 reports for this device; peer average 1.63/device2020-09: 0 reports for this device; peer average 1.27/device2020-10: 0 reports for this device; peer average 3.21/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 1.94/device2021-01: 0 reports for this device; peer average 2.15/device2021-02: 0 reports for this device; peer average 2.29/device2021-03: 0 reports for this device; peer average 3/device2021-04: 0 reports for this device; peer average 2.25/device2021-05: 0 reports for this device; peer average 1.92/device2021-06: 0 reports for this device; peer average 2.94/device2021-07: 0 reports for this device; peer average 2.11/device2021-08: 0 reports for this device; peer average 1.67/device2021-09: 0 reports for this device; peer average 2.53/device2021-10: 0 reports for this device; peer average 1.78/device2021-11: 0 reports for this device; peer average 2.21/device2021-12: 0 reports for this device; peer average 2.07/device2022-01: 0 reports for this device; peer average 3.18/device2022-02: 0 reports for this device; peer average 1.95/device2022-03: 0 reports for this device; peer average 1.72/device2022-04: 0 reports for this device; peer average 2.18/device2022-05: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 1.88/device2022-07: 0 reports for this device; peer average 1.91/device2022-08: 0 reports for this device; peer average 2.24/device2022-09: 0 reports for this device; peer average 2.29/device2022-10: 0 reports for this device; peer average 2.63/device2022-11: 0 reports for this device; peer average 2.55/device2022-12: 0 reports for this device; peer average 3.08/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 2.33/device2023-03: 0 reports for this device; peer average 3.53/device2023-04: 0 reports for this device; peer average 2.35/device2023-05: 0 reports for this device; peer average 3.06/device2023-06: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 2.07/device2023-08: 0 reports for this device; peer average 1.73/device2023-09: 0 reports for this device; peer average 2.68/device2023-10: 0 reports for this device; peer average 2.07/device2023-11: 0 reports for this device; peer average 2.35/device2023-12: 0 reports for this device; peer average 2.42/device2024-01: 0 reports for this device; peer average 1.31/device2024-02: 0 reports for this device; peer average 1.65/device2024-03: 0 reports for this device; peer average 1.7/device2024-04: 0 reports for this device; peer average 2.05/device2024-05: 0 reports for this device; peer average 3.3/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 2.6/device2024-08: 0 reports for this device; peer average 4.13/device2024-09: 0 reports for this device; peer average 1.93/device2024-10: 0 reports for this device; peer average 2.2/device2024-11: 0 reports for this device; peer average 2.35/device2024-12: 0 reports for this device; peer average 2.87/device2025-01: 0 reports for this device; peer average 6.57/device2025-02: 0 reports for this device; peer average 3.35/device2025-03: 0 reports for this device; peer average 2.83/device2025-04: 0 reports for this device; peer average 4.22/device2025-05: 0 reports for this device; peer average 2.25/device2025-06: 0 reports for this device; peer average 5.19/device2025-07: 0 reports for this device; peer average 2.14/device2025-08: 0 reports for this device; peer average 3.48/device2025-09: 0 reports for this device; peer average 3.79/device2025-10: 0 reports for this device; peer average 4.05/device2025-11: 0 reports for this device; peer average 3.4/device2025-12: 0 reports for this device; peer average 3.96/device2026-01: 0 reports for this device; peer average 2.65/device2026-02: 0 reports for this device; peer average 8.61/device2026-03: 0 reports for this device; peer average 3.77/device2026-04: 0 reports for this device; peer average 3.62/device2026-05: 0 reports for this device; peer average 5.05/device2026-06: 0 reports for this device; peer average 2.46/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.43
2019-0205.57
2019-0303.31
2019-0403.13
2019-0503.18
2019-0604.4
2019-0704.12
2019-0804.31
2019-0903
2019-1003.18
2019-1102.79
2019-1202.76
2020-0103
2020-0202
2020-0301.95
2020-0401.58
2020-0501.59
2020-0601.36
2020-0701.66
2020-0801.63
2020-0901.27
2020-1003.21
2020-1102
2020-1201.94
2021-0102.15
2021-0202.29
2021-0303
2021-0402.25
2021-0501.92
2021-0602.94
2021-0702.11
2021-0801.67
2021-0902.53
2021-1001.78
2021-1102.21
2021-1202.07
2022-0103.18
2022-0201.95
2022-0301.72
2022-0402.18
2022-0502
2022-0601.88
2022-0701.91
2022-0802.24
2022-0902.29
2022-1002.63
2022-1102.55
2022-1203.08
2023-0102
2023-0202.33
2023-0303.53
2023-0402.35
2023-0503.06
2023-0603
2023-0702.07
2023-0801.73
2023-0902.68
2023-1002.07
2023-1102.35
2023-1202.42
2024-0101.31
2024-0201.65
2024-0301.7
2024-0402.05
2024-0503.3
2024-0602
2024-0702.6
2024-0804.13
2024-0901.93
2024-1002.2
2024-1102.35
2024-1202.87
2025-0106.57
2025-0203.35
2025-0302.83
2025-0404.22
2025-0502.25
2025-0605.19
2025-0702.14
2025-0803.48
2025-0903.79
2025-1004.05
2025-1103.4
2025-1203.96
2026-0102.65
2026-0208.61
2026-0303.77
2026-0403.62
2026-0505.05
2026-0602.46
This device (reports/month)Average device in FCG (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K142377 — cites (transitively): K070759 (d1), K072045 (d1) — cited as predicate by K213896, K230015

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