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CUSTOM LAP CHOLE

Model K2260 · APPLIED MEDICAL RESOURCES CORPORATION · DI 30607915128242

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

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

HET — Laparoscope, Gynecologic (And Accessories) · Class II · 21 CFR 884.1720

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 2026-09-13 · 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.

4812152019-01: 0 reports for this device; peer average 4.35/device2019-02: 0 reports for this device; peer average 4.47/device2019-03: 0 reports for this device; peer average 4.44/device2019-04: 0 reports for this device; peer average 4.47/device2019-05: 0 reports for this device; peer average 3.69/device2019-06: 0 reports for this device; peer average 4.48/device2019-07: 0 reports for this device; peer average 3.49/device2019-08: 0 reports for this device; peer average 3.63/device2019-09: 0 reports for this device; peer average 3.51/device2019-10: 0 reports for this device; peer average 4.47/device2019-11: 0 reports for this device; peer average 3.36/device2019-12: 0 reports for this device; peer average 4.06/device2020-01: 0 reports for this device; peer average 4.53/device2020-02: 0 reports for this device; peer average 4.07/device2020-03: 0 reports for this device; peer average 4.09/device2020-04: 0 reports for this device; peer average 4.07/device2020-05: 0 reports for this device; peer average 2.72/device2020-06: 0 reports for this device; peer average 4.15/device2020-07: 0 reports for this device; peer average 3.82/device2020-08: 0 reports for this device; peer average 5.05/device2020-09: 0 reports for this device; peer average 5.36/device2020-10: 0 reports for this device; peer average 5.19/device2020-11: 0 reports for this device; peer average 6.12/device2020-12: 0 reports for this device; peer average 5.04/device2021-01: 0 reports for this device; peer average 5.15/device2021-02: 0 reports for this device; peer average 4.96/device2021-03: 0 reports for this device; peer average 6.11/device2021-04: 0 reports for this device; peer average 5.88/device2021-05: 0 reports for this device; peer average 4.79/device2021-06: 0 reports for this device; peer average 5.5/device2021-07: 0 reports for this device; peer average 4.75/device2021-08: 0 reports for this device; peer average 5.82/device2021-09: 0 reports for this device; peer average 5.36/device2021-10: 0 reports for this device; peer average 4.9/device2021-11: 0 reports for this device; peer average 4.52/device2021-12: 0 reports for this device; peer average 5.85/device2022-01: 0 reports for this device; peer average 6.04/device2022-02: 0 reports for this device; peer average 6.49/device2022-03: 0 reports for this device; peer average 6.96/device2022-04: 0 reports for this device; peer average 8.24/device2022-05: 0 reports for this device; peer average 6.72/device2022-06: 0 reports for this device; peer average 8.42/device2022-07: 0 reports for this device; peer average 7.66/device2022-08: 0 reports for this device; peer average 7.85/device2022-09: 0 reports for this device; peer average 7.13/device2022-10: 0 reports for this device; peer average 6.81/device2022-11: 0 reports for this device; peer average 6.98/device2022-12: 0 reports for this device; peer average 9.08/device2023-01: 0 reports for this device; peer average 8.25/device2023-02: 0 reports for this device; peer average 6.48/device2023-03: 0 reports for this device; peer average 8.32/device2023-04: 0 reports for this device; peer average 7.78/device2023-05: 0 reports for this device; peer average 7.35/device2023-06: 0 reports for this device; peer average 9.38/device2023-07: 0 reports for this device; peer average 7.99/device2023-08: 0 reports for this device; peer average 7.65/device2023-09: 0 reports for this device; peer average 8.22/device2023-10: 0 reports for this device; peer average 9.14/device2023-11: 0 reports for this device; peer average 9.2/device2023-12: 0 reports for this device; peer average 9.36/device2024-01: 0 reports for this device; peer average 8.22/device2024-02: 0 reports for this device; peer average 8.73/device2024-03: 0 reports for this device; peer average 7.96/device2024-04: 0 reports for this device; peer average 10.72/device2024-05: 0 reports for this device; peer average 8.64/device2024-06: 0 reports for this device; peer average 10.69/device2024-07: 0 reports for this device; peer average 10.9/device2024-08: 0 reports for this device; peer average 10.46/device2024-09: 0 reports for this device; peer average 11.45/device2024-10: 0 reports for this device; peer average 12.27/device2024-11: 0 reports for this device; peer average 8.29/device2024-12: 0 reports for this device; peer average 9.79/device2025-01: 0 reports for this device; peer average 10.22/device2025-02: 0 reports for this device; peer average 8.49/device2025-03: 0 reports for this device; peer average 10.23/device2025-04: 0 reports for this device; peer average 9.49/device2025-05: 0 reports for this device; peer average 9.11/device2025-06: 0 reports for this device; peer average 8.78/device2025-07: 0 reports for this device; peer average 8.89/device2025-08: 0 reports for this device; peer average 10.49/device2025-09: 0 reports for this device; peer average 8.44/device2025-10: 0 reports for this device; peer average 10.07/device2025-11: 0 reports for this device; peer average 10.51/device2025-12: 0 reports for this device; peer average 15.45/device2026-01: 0 reports for this device; peer average 10.06/device2026-02: 0 reports for this device; peer average 10.81/device2026-03: 0 reports for this device; peer average 13.69/device2026-04: 0 reports for this device; peer average 13.89/device2026-05: 0 reports for this device; peer average 11.71/device2026-06: 0 reports for this device; peer average 9.31/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.35
2019-0204.47
2019-0304.44
2019-0404.47
2019-0503.69
2019-0604.48
2019-0703.49
2019-0803.63
2019-0903.51
2019-1004.47
2019-1103.36
2019-1204.06
2020-0104.53
2020-0204.07
2020-0304.09
2020-0404.07
2020-0502.72
2020-0604.15
2020-0703.82
2020-0805.05
2020-0905.36
2020-1005.19
2020-1106.12
2020-1205.04
2021-0105.15
2021-0204.96
2021-0306.11
2021-0405.88
2021-0504.79
2021-0605.5
2021-0704.75
2021-0805.82
2021-0905.36
2021-1004.9
2021-1104.52
2021-1205.85
2022-0106.04
2022-0206.49
2022-0306.96
2022-0408.24
2022-0506.72
2022-0608.42
2022-0707.66
2022-0807.85
2022-0907.13
2022-1006.81
2022-1106.98
2022-1209.08
2023-0108.25
2023-0206.48
2023-0308.32
2023-0407.78
2023-0507.35
2023-0609.38
2023-0707.99
2023-0807.65
2023-0908.22
2023-1009.14
2023-1109.2
2023-1209.36
2024-0108.22
2024-0208.73
2024-0307.96
2024-04010.72
2024-0508.64
2024-06010.69
2024-07010.9
2024-08010.46
2024-09011.45
2024-10012.27
2024-1108.29
2024-1209.79
2025-01010.22
2025-0208.49
2025-03010.23
2025-0409.49
2025-0509.11
2025-0608.78
2025-0708.89
2025-08010.49
2025-0908.44
2025-10010.07
2025-11010.51
2025-12015.45
2026-01010.06
2026-02010.81
2026-03013.69
2026-04013.89
2026-05011.71
2026-0609.31
This device (reports/month)Average device in FZP, GCJ, HET, 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