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Aer-O-Scope Daily Tube Convenience Kit
Model Rev B · G.I. VIEW LTD · DI 07290016992021
FDF — Colonoscope And Accessories, Flexible/Rigid · 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
2
2019-02
0
1.76
2019-03
0
2.14
2019-04
0
2
2019-05
0
2
2019-06
0
2.95
2019-07
0
2
2019-08
0
2.04
2019-09
0
2.12
2019-10
0
2.54
2019-11
0
1.95
2019-12
0
2.17
2020-01
0
1.96
2020-02
0
2.53
2020-03
0
2.57
2020-04
0
1.83
2020-05
0
4.1
2020-06
0
2.31
2020-07
0
4.28
2020-08
0
3.18
2020-09
0
3.67
2020-10
0
4
2020-11
0
4.27
2020-12
0
6.35
2021-01
0
7.33
2021-02
0
8.72
2021-03
0
8.3
2021-04
0
7.31
2021-05
0
6.88
2021-06
0
6.49
2021-07
0
5.84
2021-08
0
5.77
2021-09
0
8.11
2021-10
0
6.42
2021-11
0
7.49
2021-12
0
8.86
2022-01
0
6.88
2022-02
0
11.17
2022-03
0
9.51
2022-04
0
10.51
2022-05
0
10.76
2022-06
0
12.08
2022-07
0
10.25
2022-08
0
10.21
2022-09
0
11.8
2022-10
0
11.35
2022-11
0
10.82
2022-12
0
11.63
2023-01
0
9.49
2023-02
0
9.79
2023-03
0
13.46
2023-04
0
14
2023-05
0
10.55
2023-06
0
11.58
2023-07
0
13.69
2023-08
0
12.2
2023-09
0
11.45
2023-10
0
13.55
2023-11
0
14.24
2023-12
0
12.75
2024-01
0
11.55
2024-02
0
12.6
2024-03
0
15.75
2024-04
0
12.27
2024-05
0
10.96
2024-06
0
11.41
2024-07
0
12.26
2024-08
0
9.66
2024-09
0
10.64
2024-10
0
13.07
2024-11
0
6.89
2024-12
0
5.79
2025-01
0
6.61
2025-02
0
6.4
2025-03
0
7.9
2025-04
0
8
2025-05
0
10.21
2025-06
0
9.74
2025-07
0
9.05
2025-08
0
11.38
2025-09
0
6.93
2025-10
0
14.79
2025-11
0
26.34
2025-12
0
57.71
2026-01
0
41.88
2026-02
0
25.8
2026-03
0
24.83
2026-04
0
32.37
2026-05
0
33.85
2026-06
0
36.71
This device (reports/month)Average device in FDF (reports/device/month)