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3G-SDI CABLE 3.0M

Model MAJ-2015 · OLYMPUS MEDICAL SYSTEMS CORP. · DI 04953170338243

FGB — Ureteroscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500

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

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

NWB — Endoscope, Accessories, Narrow Band Spectrum · Class II · 21 CFR 876.1500

UDILibrary device dossier · generated 2026-09-12 · 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.

61117232019-01: 0 reports for this device; peer average 2.88/device2019-02: 0 reports for this device; peer average 3.44/device2019-03: 0 reports for this device; peer average 3.82/device2019-04: 0 reports for this device; peer average 5.83/device2019-05: 0 reports for this device; peer average 2.88/device2019-06: 0 reports for this device; peer average 3.5/device2019-07: 0 reports for this device; peer average 3.39/device2019-08: 0 reports for this device; peer average 2.69/device2019-09: 0 reports for this device; peer average 2.57/device2019-10: 0 reports for this device; peer average 2.81/device2019-11: 0 reports for this device; peer average 2.59/device2019-12: 0 reports for this device; peer average 2.63/device2020-01: 0 reports for this device; peer average 2.68/device2020-02: 0 reports for this device; peer average 3.33/device2020-03: 0 reports for this device; peer average 2.53/device2020-04: 0 reports for this device; peer average 2.93/device2020-05: 0 reports for this device; peer average 3.09/device2020-06: 0 reports for this device; peer average 3.46/device2020-07: 0 reports for this device; peer average 4.6/device2020-08: 0 reports for this device; peer average 5.18/device2020-09: 0 reports for this device; peer average 4.94/device2020-10: 0 reports for this device; peer average 5.62/device2020-11: 0 reports for this device; peer average 6.3/device2020-12: 0 reports for this device; peer average 6.52/device2021-01: 0 reports for this device; peer average 6.64/device2021-02: 0 reports for this device; peer average 5.91/device2021-03: 0 reports for this device; peer average 8.23/device2021-04: 0 reports for this device; peer average 7.52/device2021-05: 0 reports for this device; peer average 6.84/device2021-06: 0 reports for this device; peer average 6.47/device2021-07: 0 reports for this device; peer average 6.33/device2021-08: 0 reports for this device; peer average 6.73/device2021-09: 0 reports for this device; peer average 7.65/device2021-10: 0 reports for this device; peer average 6.29/device2021-11: 0 reports for this device; peer average 6.12/device2021-12: 0 reports for this device; peer average 7.97/device2022-01: 0 reports for this device; peer average 7.88/device2022-02: 0 reports for this device; peer average 8.98/device2022-03: 0 reports for this device; peer average 10.17/device2022-04: 0 reports for this device; peer average 11.48/device2022-05: 0 reports for this device; peer average 10.23/device2022-06: 0 reports for this device; peer average 10.93/device2022-07: 0 reports for this device; peer average 10.06/device2022-08: 0 reports for this device; peer average 10.06/device2022-09: 0 reports for this device; peer average 8.78/device2022-10: 0 reports for this device; peer average 8.72/device2022-11: 0 reports for this device; peer average 8.75/device2022-12: 0 reports for this device; peer average 9.73/device2023-01: 0 reports for this device; peer average 9.3/device2023-02: 0 reports for this device; peer average 8.07/device2023-03: 0 reports for this device; peer average 10.71/device2023-04: 0 reports for this device; peer average 9.14/device2023-05: 0 reports for this device; peer average 9.08/device2023-06: 0 reports for this device; peer average 9.36/device2023-07: 0 reports for this device; peer average 8.81/device2023-08: 0 reports for this device; peer average 9.73/device2023-09: 0 reports for this device; peer average 9.62/device2023-10: 0 reports for this device; peer average 10.06/device2023-11: 0 reports for this device; peer average 9.9/device2023-12: 0 reports for this device; peer average 9.19/device2024-01: 0 reports for this device; peer average 9.5/device2024-02: 0 reports for this device; peer average 10.12/device2024-03: 0 reports for this device; peer average 10.34/device2024-04: 0 reports for this device; peer average 10.59/device2024-05: 0 reports for this device; peer average 10.32/device2024-06: 0 reports for this device; peer average 12.95/device2024-07: 0 reports for this device; peer average 12.12/device2024-08: 0 reports for this device; peer average 11.54/device2024-09: 0 reports for this device; peer average 11.8/device2024-10: 0 reports for this device; peer average 14.06/device2024-11: 0 reports for this device; peer average 8.68/device2024-12: 0 reports for this device; peer average 8.59/device2025-01: 0 reports for this device; peer average 8.83/device2025-02: 0 reports for this device; peer average 7.97/device2025-03: 0 reports for this device; peer average 8.71/device2025-04: 0 reports for this device; peer average 8.51/device2025-05: 0 reports for this device; peer average 8.29/device2025-06: 0 reports for this device; peer average 8.08/device2025-07: 0 reports for this device; peer average 8.47/device2025-08: 0 reports for this device; peer average 9.76/device2025-09: 0 reports for this device; peer average 7.24/device2025-10: 0 reports for this device; peer average 10.84/device2025-11: 0 reports for this device; peer average 13.56/device2025-12: 0 reports for this device; peer average 22.56/device2026-01: 0 reports for this device; peer average 17.57/device2026-02: 0 reports for this device; peer average 12.49/device2026-03: 0 reports for this device; peer average 14.02/device2026-04: 0 reports for this device; peer average 17.31/device2026-05: 0 reports for this device; peer average 18.43/device2026-06: 0 reports for this device; peer average 15.82/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.88
2019-0203.44
2019-0303.82
2019-0405.83
2019-0502.88
2019-0603.5
2019-0703.39
2019-0802.69
2019-0902.57
2019-1002.81
2019-1102.59
2019-1202.63
2020-0102.68
2020-0203.33
2020-0302.53
2020-0402.93
2020-0503.09
2020-0603.46
2020-0704.6
2020-0805.18
2020-0904.94
2020-1005.62
2020-1106.3
2020-1206.52
2021-0106.64
2021-0205.91
2021-0308.23
2021-0407.52
2021-0506.84
2021-0606.47
2021-0706.33
2021-0806.73
2021-0907.65
2021-1006.29
2021-1106.12
2021-1207.97
2022-0107.88
2022-0208.98
2022-03010.17
2022-04011.48
2022-05010.23
2022-06010.93
2022-07010.06
2022-08010.06
2022-0908.78
2022-1008.72
2022-1108.75
2022-1209.73
2023-0109.3
2023-0208.07
2023-03010.71
2023-0409.14
2023-0509.08
2023-0609.36
2023-0708.81
2023-0809.73
2023-0909.62
2023-10010.06
2023-1109.9
2023-1209.19
2024-0109.5
2024-02010.12
2024-03010.34
2024-04010.59
2024-05010.32
2024-06012.95
2024-07012.12
2024-08011.54
2024-09011.8
2024-10014.06
2024-1108.68
2024-1208.59
2025-0108.83
2025-0207.97
2025-0308.71
2025-0408.51
2025-0508.29
2025-0608.08
2025-0708.47
2025-0809.76
2025-0907.24
2025-10010.84
2025-11013.56
2025-12022.56
2026-01017.57
2026-02012.49
2026-03014.02
2026-04017.31
2026-05018.43
2026-06015.82
This device (reports/month)Average device in FGB, GCJ, HET, NWB (reports/device/month)

Regulatory clearances

  • K123365 SESE 2013-03-01 (k number procode)

Predicate lineage

K123365 — cites (transitively): K111425 (d1), K112680 (d1), K113203 (d1), K061313 (d2), K062049 (d2), K080948 (d2), K100584 (d2), K002749 (d2), K011151 (d2), K051645 (d2), K102379 (d2), K943304 (d3), K943307 (d3) — cited as predicate by K150525, K172796, K183675, K193026, K201832, K221642

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — OLYMPUS MEDICAL SYSTEMS CORP.

  • Warning Letter 2022-12-12 Olympus Medical Systems Corporation
  • Warning Letter 2018-03-09 Olympus Medical Systems Corporation
  • OAI 2022-09-09 Olympus Medical Systems Corporation · 1 citations
  • OAI 2015-04-24 Olympus Medical Systems Corporation · 2 citations