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All-Channnel Irrigator
Model CW-4 · OLYMPUS MEDICAL SYSTEMS CORP. · DI 04953170355707
FDF — Colonoscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500
FDS — Gastroscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500
FDT — Duodenoscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500
ODG — Endoscopic Ultrasound System, Gastroenterology-Urology · 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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
3.41
2019-02
0
2.48
2019-03
0
2.73
2019-04
0
2.24
2019-05
0
3.29
2019-06
0
3.45
2019-07
0
4.65
2019-08
0
2.37
2019-09
0
2.47
2019-10
0
2.78
2019-11
0
3.33
2019-12
0
3.02
2020-01
0
2.21
2020-02
0
3.67
2020-03
0
3.05
2020-04
0
2.57
2020-05
0
5.49
2020-06
0
3.05
2020-07
0
6.85
2020-08
0
4.2
2020-09
0
4.55
2020-10
0
5.2
2020-11
0
5.21
2020-12
0
8.21
2021-01
0
7.96
2021-02
0
9.19
2021-03
0
10.16
2021-04
0
9.43
2021-05
0
8.48
2021-06
0
8.29
2021-07
0
8.13
2021-08
0
7.89
2021-09
0
11.13
2021-10
0
7.96
2021-11
0
9.41
2021-12
0
11.57
2022-01
0
9.29
2022-02
0
12.56
2022-03
0
11.67
2022-04
0
12.43
2022-05
0
11.83
2022-06
0
12.78
2022-07
0
11.76
2022-08
0
11.77
2022-09
0
11.78
2022-10
0
11.51
2022-11
0
10.8
2022-12
0
11.77
2023-01
0
9.84
2023-02
0
9.97
2023-03
0
12.8
2023-04
0
12.64
2023-05
0
10.93
2023-06
0
11.48
2023-07
0
12.6
2023-08
0
12.65
2023-09
0
11.32
2023-10
0
13.33
2023-11
0
13.37
2023-12
0
12.25
2024-01
0
12.85
2024-02
0
12.34
2024-03
0
14.92
2024-04
0
11.72
2024-05
0
10.62
2024-06
0
11.16
2024-07
0
11.45
2024-08
0
9.56
2024-09
0
9.45
2024-10
0
12.23
2024-11
0
6.33
2024-12
0
5.16
2025-01
0
6.08
2025-02
0
5.9
2025-03
0
7.42
2025-04
0
7.48
2025-05
0
8.49
2025-06
0
8.95
2025-07
0
8.1
2025-08
0
10.01
2025-09
0
7.13
2025-10
0
13.68
2025-11
0
24.23
2025-12
0
47.75
2026-01
0
36.09
2026-02
0
20.76
2026-03
0
20.81
2026-04
0
29.02
2026-05
0
30.07
2026-06
0
30.8
This device (reports/month)Average device in FDF, FDS, FDT, ODG (reports/device/month)
Regulatory clearances
None linked in the loaded window.
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