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Acucise® Endopyelotomy System

Model B1005 · APPLIED MEDICAL RESOURCES CORPORATION · DI 00607915111663

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

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

ODC — Endoscope Channel Accessory · Class II · 21 CFR 876.1500

UDILibrary device dossier · generated 2026-09-15 · 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.

3710132019-01: 0 reports for this device; peer average 1.89/device2019-02: 0 reports for this device; peer average 1.42/device2019-03: 0 reports for this device; peer average 2.11/device2019-04: 0 reports for this device; peer average 1.43/device2019-05: 0 reports for this device; peer average 1.55/device2019-06: 0 reports for this device; peer average 2.64/device2019-07: 0 reports for this device; peer average 1.72/device2019-08: 0 reports for this device; peer average 1.55/device2019-09: 0 reports for this device; peer average 1.27/device2019-10: 0 reports for this device; peer average 1.91/device2019-11: 0 reports for this device; peer average 1.41/device2019-12: 0 reports for this device; peer average 1.65/device2020-01: 0 reports for this device; peer average 1.67/device2020-02: 0 reports for this device; peer average 1.45/device2020-03: 0 reports for this device; peer average 1.55/device2020-04: 0 reports for this device; peer average 2.67/device2020-05: 0 reports for this device; peer average 1.2/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2.06/device2020-08: 0 reports for this device; peer average 1.85/device2020-09: 0 reports for this device; peer average 2.18/device2020-10: 0 reports for this device; peer average 2.37/device2020-11: 0 reports for this device; peer average 2.07/device2020-12: 0 reports for this device; peer average 2.43/device2021-01: 0 reports for this device; peer average 1.55/device2021-02: 0 reports for this device; peer average 2.63/device2021-03: 0 reports for this device; peer average 1.77/device2021-04: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 1.45/device2021-06: 0 reports for this device; peer average 2.19/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1.59/device2021-09: 0 reports for this device; peer average 1.8/device2021-10: 0 reports for this device; peer average 1.5/device2021-11: 0 reports for this device; peer average 2.4/device2021-12: 0 reports for this device; peer average 1.47/device2022-01: 0 reports for this device; peer average 1.75/device2022-02: 0 reports for this device; peer average 1.55/device2022-03: 0 reports for this device; peer average 1.5/device2022-04: 0 reports for this device; peer average 2.27/device2022-05: 0 reports for this device; peer average 2.78/device2022-06: 0 reports for this device; peer average 2.07/device2022-07: 0 reports for this device; peer average 1.93/device2022-08: 0 reports for this device; peer average 1.82/device2022-09: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 1.69/device2022-11: 0 reports for this device; peer average 2.77/device2022-12: 0 reports for this device; peer average 1.63/device2023-01: 0 reports for this device; peer average 2.43/device2023-02: 0 reports for this device; peer average 1.76/device2023-03: 0 reports for this device; peer average 3.25/device2023-04: 0 reports for this device; peer average 2.68/device2023-05: 0 reports for this device; peer average 3.46/device2023-06: 0 reports for this device; peer average 2.36/device2023-07: 0 reports for this device; peer average 2.29/device2023-08: 0 reports for this device; peer average 2.63/device2023-09: 0 reports for this device; peer average 3.63/device2023-10: 0 reports for this device; peer average 1.52/device2023-11: 0 reports for this device; peer average 2.76/device2023-12: 0 reports for this device; peer average 2.2/device2024-01: 0 reports for this device; peer average 2.14/device2024-02: 0 reports for this device; peer average 1.4/device2024-03: 0 reports for this device; peer average 2.22/device2024-04: 0 reports for this device; peer average 1.6/device2024-05: 0 reports for this device; peer average 2.56/device2024-06: 0 reports for this device; peer average 1.47/device2024-07: 0 reports for this device; peer average 2.88/device2024-08: 0 reports for this device; peer average 2.63/device2024-09: 0 reports for this device; peer average 1.71/device2024-10: 0 reports for this device; peer average 3.61/device2024-11: 0 reports for this device; peer average 2.05/device2024-12: 0 reports for this device; peer average 1.64/device2025-01: 0 reports for this device; peer average 1.87/device2025-02: 0 reports for this device; peer average 1.78/device2025-03: 0 reports for this device; peer average 1.82/device2025-04: 0 reports for this device; peer average 2.04/device2025-05: 0 reports for this device; peer average 4.25/device2025-06: 0 reports for this device; peer average 1.73/device2025-07: 0 reports for this device; peer average 2.71/device2025-08: 0 reports for this device; peer average 2.14/device2025-09: 0 reports for this device; peer average 1.7/device2025-10: 0 reports for this device; peer average 2.16/device2025-11: 0 reports for this device; peer average 3.94/device2025-12: 0 reports for this device; peer average 1.93/device2026-01: 0 reports for this device; peer average 1.95/device2026-02: 0 reports for this device; peer average 3.42/device2026-03: 0 reports for this device; peer average 3/device2026-04: 0 reports for this device; peer average 2.38/device2026-05: 0 reports for this device; peer average 13.4/device2026-06: 0 reports for this device; peer average 2.2/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.89
2019-0201.42
2019-0302.11
2019-0401.43
2019-0501.55
2019-0602.64
2019-0701.72
2019-0801.55
2019-0901.27
2019-1001.91
2019-1101.41
2019-1201.65
2020-0101.67
2020-0201.45
2020-0301.55
2020-0402.67
2020-0501.2
2020-0602
2020-0702.06
2020-0801.85
2020-0902.18
2020-1002.37
2020-1102.07
2020-1202.43
2021-0101.55
2021-0202.63
2021-0301.77
2021-0402
2021-0501.45
2021-0602.19
2021-0702
2021-0801.59
2021-0901.8
2021-1001.5
2021-1102.4
2021-1201.47
2022-0101.75
2022-0201.55
2022-0301.5
2022-0402.27
2022-0502.78
2022-0602.07
2022-0701.93
2022-0801.82
2022-0902
2022-1001.69
2022-1102.77
2022-1201.63
2023-0102.43
2023-0201.76
2023-0303.25
2023-0402.68
2023-0503.46
2023-0602.36
2023-0702.29
2023-0802.63
2023-0903.63
2023-1001.52
2023-1102.76
2023-1202.2
2024-0102.14
2024-0201.4
2024-0302.22
2024-0401.6
2024-0502.56
2024-0601.47
2024-0702.88
2024-0802.63
2024-0901.71
2024-1003.61
2024-1102.05
2024-1201.64
2025-0101.87
2025-0201.78
2025-0301.82
2025-0402.04
2025-0504.25
2025-0601.73
2025-0702.71
2025-0802.14
2025-0901.7
2025-1002.16
2025-1103.94
2025-1201.93
2026-0101.95
2026-0203.42
2026-0303
2026-0402.38
2026-05013.4
2026-0602.2
This device (reports/month)Average device in DXT, EYB, EZB, KNY, ODC (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