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BioGuard
Model 00711780 · US Endoscopy · DI 00816765012772
FDF — Colonoscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500
ODC — Endoscope Channel Accessory · 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
1.75
2019-03
0
2.28
2019-04
0
2
2019-05
0
1.94
2019-06
0
2.91
2019-07
0
2
2019-08
0
2
2019-09
0
2
2019-10
0
2.74
2019-11
0
1.96
2019-12
0
2.13
2020-01
0
1.86
2020-02
0
2.43
2020-03
0
2.61
2020-04
0
1.83
2020-05
0
4
2020-06
0
2.26
2020-07
0
4.18
2020-08
0
3.12
2020-09
0
3.6
2020-10
0
4.17
2020-11
0
4.36
2020-12
0
6.22
2021-01
0
7.17
2021-02
0
8.35
2021-03
0
8.26
2021-04
0
7.14
2021-05
0
6.69
2021-06
0
6.31
2021-07
0
5.68
2021-08
0
5.65
2021-09
0
7.98
2021-10
0
6.42
2021-11
0
7.47
2021-12
0
8.81
2022-01
0
6.88
2022-02
0
10.98
2022-03
0
9.32
2022-04
0
10.36
2022-05
0
10.65
2022-06
0
11.47
2022-07
0
10.08
2022-08
0
9.78
2022-09
0
11.21
2022-10
0
10.76
2022-11
0
10.33
2022-12
0
10.9
2023-01
0
9.09
2023-02
0
9.34
2023-03
0
13.21
2023-04
0
13.5
2023-05
0
10.33
2023-06
0
11.58
2023-07
0
13.38
2023-08
0
12.1
2023-09
0
11.28
2023-10
0
13.55
2023-11
0
13.93
2023-12
0
12.45
2024-01
0
11.23
2024-02
0
12.24
2024-03
0
15.67
2024-04
0
12.15
2024-05
0
10.68
2024-06
0
10.95
2024-07
0
11.86
2024-08
0
9.54
2024-09
0
10.38
2024-10
0
12.83
2024-11
0
6.69
2024-12
0
5.61
2025-01
0
6.48
2025-02
0
6.19
2025-03
0
7.51
2025-04
0
7.13
2025-05
0
10.03
2025-06
0
9.53
2025-07
0
8.81
2025-08
0
10.24
2025-09
0
6.01
2025-10
0
14.33
2025-11
0
25.79
2025-12
0
56.43
2026-01
0
37.94
2026-02
0
23.84
2026-03
0
23.83
2026-04
0
30.53
2026-05
0
33.29
2026-06
0
34.82
This device (reports/month)Average device in FDF, ODC (reports/device/month)
Regulatory clearances
K192059 SESE 2019-09-17 (k number procode)
Predicate lineage
K192059 — cited as predicate by K202104, K203630
Lineage extracted from public 510(k) summary text (heuristic).