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ACUCISE® PROCEDURAL PACK

Model BK021 · APPLIED MEDICAL RESOURCES CORPORATION · DI 20607915128160

DXT — Injector And Syringe, Angiographic · Class II · 21 CFR 870.1650

EYB — Catheter, Ureteral, Gastro-Urology · Class II · 21 CFR 876.5130

EZB — Stylet For Catheter, Gastro-Urology · Class I · 21 CFR 876.5130

FAD — Stent, Ureteral · Class II · 21 CFR 876.4620

FED — Endoscopic Access Overtube, Gastroenterology-Urology · Class II · 21 CFR 876.1500

FZP — Clip, Implantable · Class II · 21 CFR 878.4300

KNY — Accessories, Catheter, G-U · Class II · 21 CFR 876.5130

MDM — Instrument, Manual, Surgical, General Use · Class I · 21 CFR 878.4800

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 (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.

257102019-01: 0 reports for this device; peer average 5.66/device2019-02: 0 reports for this device; peer average 4.79/device2019-03: 0 reports for this device; peer average 5.73/device2019-04: 0 reports for this device; peer average 5.24/device2019-05: 0 reports for this device; peer average 5.6/device2019-06: 0 reports for this device; peer average 5.29/device2019-07: 0 reports for this device; peer average 4.49/device2019-08: 0 reports for this device; peer average 4.16/device2019-09: 0 reports for this device; peer average 3.8/device2019-10: 0 reports for this device; peer average 4.98/device2019-11: 0 reports for this device; peer average 3.93/device2019-12: 0 reports for this device; peer average 4.89/device2020-01: 0 reports for this device; peer average 5.87/device2020-02: 0 reports for this device; peer average 4.86/device2020-03: 0 reports for this device; peer average 5.38/device2020-04: 0 reports for this device; peer average 6.49/device2020-05: 0 reports for this device; peer average 3.34/device2020-06: 0 reports for this device; peer average 5.58/device2020-07: 0 reports for this device; peer average 4.45/device2020-08: 0 reports for this device; peer average 4.79/device2020-09: 0 reports for this device; peer average 5.14/device2020-10: 0 reports for this device; peer average 5.38/device2020-11: 0 reports for this device; peer average 5.96/device2020-12: 0 reports for this device; peer average 4.83/device2021-01: 0 reports for this device; peer average 4.82/device2021-02: 0 reports for this device; peer average 4.98/device2021-03: 0 reports for this device; peer average 5.53/device2021-04: 0 reports for this device; peer average 4.31/device2021-05: 0 reports for this device; peer average 3.41/device2021-06: 0 reports for this device; peer average 4.54/device2021-07: 0 reports for this device; peer average 4.19/device2021-08: 0 reports for this device; peer average 6.21/device2021-09: 0 reports for this device; peer average 5.12/device2021-10: 0 reports for this device; peer average 4.38/device2021-11: 0 reports for this device; peer average 4.54/device2021-12: 0 reports for this device; peer average 4.11/device2022-01: 0 reports for this device; peer average 4.97/device2022-02: 0 reports for this device; peer average 3.86/device2022-03: 0 reports for this device; peer average 4.67/device2022-04: 0 reports for this device; peer average 5.28/device2022-05: 0 reports for this device; peer average 4.45/device2022-06: 0 reports for this device; peer average 6.36/device2022-07: 0 reports for this device; peer average 4.13/device2022-08: 0 reports for this device; peer average 4.51/device2022-09: 0 reports for this device; peer average 4.68/device2022-10: 0 reports for this device; peer average 4.79/device2022-11: 0 reports for this device; peer average 4.4/device2022-12: 0 reports for this device; peer average 6.04/device2023-01: 0 reports for this device; peer average 6/device2023-02: 0 reports for this device; peer average 4.11/device2023-03: 0 reports for this device; peer average 4.67/device2023-04: 0 reports for this device; peer average 5.38/device2023-05: 0 reports for this device; peer average 3.99/device2023-06: 0 reports for this device; peer average 6.05/device2023-07: 0 reports for this device; peer average 5.56/device2023-08: 0 reports for this device; peer average 4.35/device2023-09: 0 reports for this device; peer average 5.28/device2023-10: 0 reports for this device; peer average 6.53/device2023-11: 0 reports for this device; peer average 7.44/device2023-12: 0 reports for this device; peer average 9.53/device2024-01: 0 reports for this device; peer average 6.46/device2024-02: 0 reports for this device; peer average 7.67/device2024-03: 0 reports for this device; peer average 6.16/device2024-04: 0 reports for this device; peer average 9.57/device2024-05: 0 reports for this device; peer average 4.77/device2024-06: 0 reports for this device; peer average 4.26/device2024-07: 0 reports for this device; peer average 4.55/device2024-08: 0 reports for this device; peer average 4.31/device2024-09: 0 reports for this device; peer average 5.27/device2024-10: 0 reports for this device; peer average 5.6/device2024-11: 0 reports for this device; peer average 5.34/device2024-12: 0 reports for this device; peer average 4.99/device2025-01: 0 reports for this device; peer average 5.59/device2025-02: 0 reports for this device; peer average 4.22/device2025-03: 0 reports for this device; peer average 6.17/device2025-04: 0 reports for this device; peer average 5.83/device2025-05: 0 reports for this device; peer average 7.5/device2025-06: 0 reports for this device; peer average 6.47/device2025-07: 0 reports for this device; peer average 5.99/device2025-08: 0 reports for this device; peer average 5.68/device2025-09: 0 reports for this device; peer average 5.96/device2025-10: 0 reports for this device; peer average 6.42/device2025-11: 0 reports for this device; peer average 5.25/device2025-12: 0 reports for this device; peer average 8.57/device2026-01: 0 reports for this device; peer average 7.36/device2026-02: 0 reports for this device; peer average 8.24/device2026-03: 0 reports for this device; peer average 7.74/device2026-04: 0 reports for this device; peer average 7.47/device2026-05: 0 reports for this device; peer average 6.2/device2026-06: 0 reports for this device; peer average 5.26/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0105.66
2019-0204.79
2019-0305.73
2019-0405.24
2019-0505.6
2019-0605.29
2019-0704.49
2019-0804.16
2019-0903.8
2019-1004.98
2019-1103.93
2019-1204.89
2020-0105.87
2020-0204.86
2020-0305.38
2020-0406.49
2020-0503.34
2020-0605.58
2020-0704.45
2020-0804.79
2020-0905.14
2020-1005.38
2020-1105.96
2020-1204.83
2021-0104.82
2021-0204.98
2021-0305.53
2021-0404.31
2021-0503.41
2021-0604.54
2021-0704.19
2021-0806.21
2021-0905.12
2021-1004.38
2021-1104.54
2021-1204.11
2022-0104.97
2022-0203.86
2022-0304.67
2022-0405.28
2022-0504.45
2022-0606.36
2022-0704.13
2022-0804.51
2022-0904.68
2022-1004.79
2022-1104.4
2022-1206.04
2023-0106
2023-0204.11
2023-0304.67
2023-0405.38
2023-0503.99
2023-0606.05
2023-0705.56
2023-0804.35
2023-0905.28
2023-1006.53
2023-1107.44
2023-1209.53
2024-0106.46
2024-0207.67
2024-0306.16
2024-0409.57
2024-0504.77
2024-0604.26
2024-0704.55
2024-0804.31
2024-0905.27
2024-1005.6
2024-1105.34
2024-1204.99
2025-0105.59
2025-0204.22
2025-0306.17
2025-0405.83
2025-0507.5
2025-0606.47
2025-0705.99
2025-0805.68
2025-0905.96
2025-1006.42
2025-1105.25
2025-1208.57
2026-0107.36
2026-0208.24
2026-0307.74
2026-0407.47
2026-0506.2
2026-0605.26
This device (reports/month)Average device in DXT, EYB, EZB, FAD, FED, FZP, KNY, MDM (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — APPLIED MEDICAL RESOURCES CORPORATION

  • Warning Letter 2015-04-10 Applied Medical Resources Corp
  • Warning Letter 2015-04-10 Applied Medical Resources Corp
  • NAI 2021-09-02 Applied Medical Resources Corp · 0 citations
  • NAI 2021-09-02 Applied Medical Resources Corp · 0 citations
  • NAI 2018-11-20 Applied Medical Resources Corp · 0 citations
  • NAI 2018-11-20 Applied Medical Resources Corp · 0 citations
  • VAI 2017-03-31 Applied Medical Resources Corp · 0 citations
  • VAI 2017-03-31 Applied Medical Resources Corp · 0 citations
  • NAI 2015-12-03 Applied Medical Resources Corporation · 0 citations
  • OAI 2015-10-14 Applied Medical Resources Corp · 8 citations
  • OAI 2015-10-14 Applied Medical Resources Corp · 8 citations
  • OAI 2014-12-16 Applied Medical Resources Corp · 8 citations
  • NAI 2014-12-16 Applied Medical Distribution Center · 0 citations
  • OAI 2014-12-16 Applied Medical Resources Corp · 8 citations