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DR. ELFRINK - LAP CHOLECYSTECTOMY

Model K2321 · APPLIED MEDICAL RESOURCES CORPORATION · DI 30607915129942

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

GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500

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

NWV — Laparoscopic Accessories, Gynecologic · Class I · 21 CFR 884.1720

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.

24792019-01: 0 reports for this device; peer average 4.36/device2019-02: 0 reports for this device; peer average 4.5/device2019-03: 0 reports for this device; peer average 4.5/device2019-04: 0 reports for this device; peer average 4.57/device2019-05: 0 reports for this device; peer average 3.78/device2019-06: 0 reports for this device; peer average 4.61/device2019-07: 0 reports for this device; peer average 3.54/device2019-08: 0 reports for this device; peer average 3.64/device2019-09: 0 reports for this device; peer average 3.57/device2019-10: 0 reports for this device; peer average 4.58/device2019-11: 0 reports for this device; peer average 3.4/device2019-12: 0 reports for this device; peer average 4.08/device2020-01: 0 reports for this device; peer average 4.65/device2020-02: 0 reports for this device; peer average 4.22/device2020-03: 0 reports for this device; peer average 4.14/device2020-04: 0 reports for this device; peer average 4.07/device2020-05: 0 reports for this device; peer average 2.71/device2020-06: 0 reports for this device; peer average 4.14/device2020-07: 0 reports for this device; peer average 3.72/device2020-08: 0 reports for this device; peer average 4.97/device2020-09: 0 reports for this device; peer average 5.35/device2020-10: 0 reports for this device; peer average 5.11/device2020-11: 0 reports for this device; peer average 5.93/device2020-12: 0 reports for this device; peer average 4.82/device2021-01: 0 reports for this device; peer average 5.03/device2021-02: 0 reports for this device; peer average 4.89/device2021-03: 0 reports for this device; peer average 5.81/device2021-04: 0 reports for this device; peer average 5.49/device2021-05: 0 reports for this device; peer average 4.34/device2021-06: 0 reports for this device; peer average 5.14/device2021-07: 0 reports for this device; peer average 4.6/device2021-08: 0 reports for this device; peer average 5.64/device2021-09: 0 reports for this device; peer average 5.15/device2021-10: 0 reports for this device; peer average 4.65/device2021-11: 0 reports for this device; peer average 4.4/device2021-12: 0 reports for this device; peer average 5.44/device2022-01: 0 reports for this device; peer average 5.26/device2022-02: 0 reports for this device; peer average 5.27/device2022-03: 0 reports for this device; peer average 5.83/device2022-04: 0 reports for this device; peer average 7/device2022-05: 0 reports for this device; peer average 5.73/device2022-06: 0 reports for this device; peer average 7.17/device2022-07: 0 reports for this device; peer average 6.41/device2022-08: 0 reports for this device; peer average 6.72/device2022-09: 0 reports for this device; peer average 6.14/device2022-10: 0 reports for this device; peer average 5.94/device2022-11: 0 reports for this device; peer average 5.94/device2022-12: 0 reports for this device; peer average 7.09/device2023-01: 0 reports for this device; peer average 6.17/device2023-02: 0 reports for this device; peer average 5.3/device2023-03: 0 reports for this device; peer average 6.21/device2023-04: 0 reports for this device; peer average 6.41/device2023-05: 0 reports for this device; peer average 5.97/device2023-06: 0 reports for this device; peer average 8.09/device2023-07: 0 reports for this device; peer average 6.7/device2023-08: 0 reports for this device; peer average 6.39/device2023-09: 0 reports for this device; peer average 6.63/device2023-10: 0 reports for this device; peer average 7.87/device2023-11: 0 reports for this device; peer average 7.81/device2023-12: 0 reports for this device; peer average 8.35/device2024-01: 0 reports for this device; peer average 7.22/device2024-02: 0 reports for this device; peer average 7.92/device2024-03: 0 reports for this device; peer average 6.77/device2024-04: 0 reports for this device; peer average 8.78/device2024-05: 0 reports for this device; peer average 5.46/device2024-06: 0 reports for this device; peer average 6.56/device2024-07: 0 reports for this device; peer average 6.2/device2024-08: 0 reports for this device; peer average 6.66/device2024-09: 0 reports for this device; peer average 7.04/device2024-10: 0 reports for this device; peer average 7.86/device2024-11: 0 reports for this device; peer average 5.7/device2024-12: 0 reports for this device; peer average 5.9/device2025-01: 0 reports for this device; peer average 5.39/device2025-02: 0 reports for this device; peer average 4.57/device2025-03: 0 reports for this device; peer average 6.47/device2025-04: 0 reports for this device; peer average 6.06/device2025-05: 0 reports for this device; peer average 6.03/device2025-06: 0 reports for this device; peer average 6.01/device2025-07: 0 reports for this device; peer average 5.94/device2025-08: 0 reports for this device; peer average 6.8/device2025-09: 0 reports for this device; peer average 5.55/device2025-10: 0 reports for this device; peer average 6.35/device2025-11: 0 reports for this device; peer average 5.83/device2025-12: 0 reports for this device; peer average 8.53/device2026-01: 0 reports for this device; peer average 6.5/device2026-02: 0 reports for this device; peer average 6.82/device2026-03: 0 reports for this device; peer average 7.46/device2026-04: 0 reports for this device; peer average 8.23/device2026-05: 0 reports for this device; peer average 6.62/device2026-06: 0 reports for this device; peer average 5.98/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.36
2019-0204.5
2019-0304.5
2019-0404.57
2019-0503.78
2019-0604.61
2019-0703.54
2019-0803.64
2019-0903.57
2019-1004.58
2019-1103.4
2019-1204.08
2020-0104.65
2020-0204.22
2020-0304.14
2020-0404.07
2020-0502.71
2020-0604.14
2020-0703.72
2020-0804.97
2020-0905.35
2020-1005.11
2020-1105.93
2020-1204.82
2021-0105.03
2021-0204.89
2021-0305.81
2021-0405.49
2021-0504.34
2021-0605.14
2021-0704.6
2021-0805.64
2021-0905.15
2021-1004.65
2021-1104.4
2021-1205.44
2022-0105.26
2022-0205.27
2022-0305.83
2022-0407
2022-0505.73
2022-0607.17
2022-0706.41
2022-0806.72
2022-0906.14
2022-1005.94
2022-1105.94
2022-1207.09
2023-0106.17
2023-0205.3
2023-0306.21
2023-0406.41
2023-0505.97
2023-0608.09
2023-0706.7
2023-0806.39
2023-0906.63
2023-1007.87
2023-1107.81
2023-1208.35
2024-0107.22
2024-0207.92
2024-0306.77
2024-0408.78
2024-0505.46
2024-0606.56
2024-0706.2
2024-0806.66
2024-0907.04
2024-1007.86
2024-1105.7
2024-1205.9
2025-0105.39
2025-0204.57
2025-0306.47
2025-0406.06
2025-0506.03
2025-0606.01
2025-0705.94
2025-0806.8
2025-0905.55
2025-1006.35
2025-1105.83
2025-1208.53
2026-0106.5
2026-0206.82
2026-0307.46
2026-0408.23
2026-0506.62
2026-0605.98
This device (reports/month)Average device in FZP, GCJ, MDM, NWV (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