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KIT KE226 COLON

Model GK253 · APPLIED MEDICAL RESOURCES CORPORATION · DI 20607915133898

FHF — System, Evacuator, Fluid · Class II · 21 CFR 876.4370

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

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

GEI — Electrosurgical, Cutting & Coagulation & Accessories · Class II · 21 CFR 878.4400

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

KKX — Drape, Surgical, Antimicrobial · Class II · 21 CFR 878.4370

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 2026-09-06 · 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.

358112019-01: 0 reports for this device; peer average 5.78/device2019-02: 0 reports for this device; peer average 4.38/device2019-03: 0 reports for this device; peer average 4.43/device2019-04: 0 reports for this device; peer average 5.36/device2019-05: 0 reports for this device; peer average 4.31/device2019-06: 0 reports for this device; peer average 4.78/device2019-07: 0 reports for this device; peer average 4.79/device2019-08: 0 reports for this device; peer average 5.03/device2019-09: 0 reports for this device; peer average 4.33/device2019-10: 0 reports for this device; peer average 5.25/device2019-11: 0 reports for this device; peer average 4.6/device2019-12: 0 reports for this device; peer average 4.78/device2020-01: 0 reports for this device; peer average 4.67/device2020-02: 0 reports for this device; peer average 4.86/device2020-03: 0 reports for this device; peer average 4.97/device2020-04: 0 reports for this device; peer average 3.79/device2020-05: 0 reports for this device; peer average 3.32/device2020-06: 0 reports for this device; peer average 4.66/device2020-07: 0 reports for this device; peer average 5.13/device2020-08: 0 reports for this device; peer average 4.82/device2020-09: 0 reports for this device; peer average 5.65/device2020-10: 0 reports for this device; peer average 5.36/device2020-11: 0 reports for this device; peer average 5.51/device2020-12: 0 reports for this device; peer average 5.18/device2021-01: 0 reports for this device; peer average 5.13/device2021-02: 0 reports for this device; peer average 4.91/device2021-03: 0 reports for this device; peer average 5.86/device2021-04: 0 reports for this device; peer average 5.54/device2021-05: 0 reports for this device; peer average 4.95/device2021-06: 0 reports for this device; peer average 5.66/device2021-07: 0 reports for this device; peer average 4.82/device2021-08: 0 reports for this device; peer average 5.06/device2021-09: 0 reports for this device; peer average 5.02/device2021-10: 0 reports for this device; peer average 5.49/device2021-11: 0 reports for this device; peer average 4.91/device2021-12: 0 reports for this device; peer average 5.69/device2022-01: 0 reports for this device; peer average 5.57/device2022-02: 0 reports for this device; peer average 5.77/device2022-03: 0 reports for this device; peer average 6.37/device2022-04: 0 reports for this device; peer average 6.54/device2022-05: 0 reports for this device; peer average 6.24/device2022-06: 0 reports for this device; peer average 7.28/device2022-07: 0 reports for this device; peer average 6.02/device2022-08: 0 reports for this device; peer average 6.12/device2022-09: 0 reports for this device; peer average 5.97/device2022-10: 0 reports for this device; peer average 5.84/device2022-11: 0 reports for this device; peer average 5.84/device2022-12: 0 reports for this device; peer average 6.65/device2023-01: 0 reports for this device; peer average 6.87/device2023-02: 0 reports for this device; peer average 5.54/device2023-03: 0 reports for this device; peer average 6.57/device2023-04: 0 reports for this device; peer average 6.37/device2023-05: 0 reports for this device; peer average 6.31/device2023-06: 0 reports for this device; peer average 7.09/device2023-07: 0 reports for this device; peer average 6.36/device2023-08: 0 reports for this device; peer average 6.2/device2023-09: 0 reports for this device; peer average 6.73/device2023-10: 0 reports for this device; peer average 7.12/device2023-11: 0 reports for this device; peer average 6.93/device2023-12: 0 reports for this device; peer average 7.17/device2024-01: 0 reports for this device; peer average 6.88/device2024-02: 0 reports for this device; peer average 7.15/device2024-03: 0 reports for this device; peer average 7.03/device2024-04: 0 reports for this device; peer average 8.3/device2024-05: 0 reports for this device; peer average 7.68/device2024-06: 0 reports for this device; peer average 8.4/device2024-07: 0 reports for this device; peer average 8.08/device2024-08: 0 reports for this device; peer average 7.76/device2024-09: 0 reports for this device; peer average 8.43/device2024-10: 0 reports for this device; peer average 9.2/device2024-11: 0 reports for this device; peer average 6.89/device2024-12: 0 reports for this device; peer average 6.98/device2025-01: 0 reports for this device; peer average 7.88/device2025-02: 0 reports for this device; peer average 6.46/device2025-03: 0 reports for this device; peer average 8.17/device2025-04: 0 reports for this device; peer average 6.79/device2025-05: 0 reports for this device; peer average 7.21/device2025-06: 0 reports for this device; peer average 6.8/device2025-07: 0 reports for this device; peer average 7.02/device2025-08: 0 reports for this device; peer average 7.95/device2025-09: 0 reports for this device; peer average 6.57/device2025-10: 0 reports for this device; peer average 7.59/device2025-11: 0 reports for this device; peer average 8.25/device2025-12: 0 reports for this device; peer average 10.69/device2026-01: 0 reports for this device; peer average 8.08/device2026-02: 0 reports for this device; peer average 8.38/device2026-03: 0 reports for this device; peer average 9.98/device2026-04: 0 reports for this device; peer average 9.89/device2026-05: 0 reports for this device; peer average 9.01/device2026-06: 0 reports for this device; peer average 7.35/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0105.78
2019-0204.38
2019-0304.43
2019-0405.36
2019-0504.31
2019-0604.78
2019-0704.79
2019-0805.03
2019-0904.33
2019-1005.25
2019-1104.6
2019-1204.78
2020-0104.67
2020-0204.86
2020-0304.97
2020-0403.79
2020-0503.32
2020-0604.66
2020-0705.13
2020-0804.82
2020-0905.65
2020-1005.36
2020-1105.51
2020-1205.18
2021-0105.13
2021-0204.91
2021-0305.86
2021-0405.54
2021-0504.95
2021-0605.66
2021-0704.82
2021-0805.06
2021-0905.02
2021-1005.49
2021-1104.91
2021-1205.69
2022-0105.57
2022-0205.77
2022-0306.37
2022-0406.54
2022-0506.24
2022-0607.28
2022-0706.02
2022-0806.12
2022-0905.97
2022-1005.84
2022-1105.84
2022-1206.65
2023-0106.87
2023-0205.54
2023-0306.57
2023-0406.37
2023-0506.31
2023-0607.09
2023-0706.36
2023-0806.2
2023-0906.73
2023-1007.12
2023-1106.93
2023-1207.17
2024-0106.88
2024-0207.15
2024-0307.03
2024-0408.3
2024-0507.68
2024-0608.4
2024-0708.08
2024-0807.76
2024-0908.43
2024-1009.2
2024-1106.89
2024-1206.98
2025-0107.88
2025-0206.46
2025-0308.17
2025-0406.79
2025-0507.21
2025-0606.8
2025-0707.02
2025-0807.95
2025-0906.57
2025-1007.59
2025-1108.25
2025-12010.69
2026-0108.08
2026-0208.38
2026-0309.98
2026-0409.89
2026-0509.01
2026-0607.35
This device (reports/month)Average device in FHF, FZP, GCJ, GEI, HET, KKX, 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