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Assurance
Model 00711883 · US Endoscopy · DI 00724995190521
PKL — Hemostatic Metal Clip For The Gi Tract · Class II · 21 CFR 876.4400
UDILibrary device dossier · generated 2026-09-11 · 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
4.56
2019-02
0
4.07
2019-03
0
6.92
2019-04
0
10.92
2019-05
0
10.73
2019-06
0
10
2019-07
0
8.45
2019-08
0
13.22
2019-09
0
6.82
2019-10
0
7.62
2019-11
0
25.4
2019-12
0
11.23
2020-01
0
12.8
2020-02
0
5.92
2020-03
0
7.67
2020-04
0
7.83
2020-05
0
8.67
2020-06
0
5.5
2020-07
0
11.4
2020-08
0
19
2020-09
0
8
2020-10
0
6
2020-11
0
6.9
2020-12
0
6.3
2021-01
0
6.56
2021-02
0
3.92
2021-03
0
3.55
2021-04
0
6.31
2021-05
0
9.33
2021-06
0
9.86
2021-07
0
11.29
2021-08
0
11.58
2021-09
0
9.1
2021-10
0
12.5
2021-11
0
8.75
2021-12
0
9.83
2022-01
0
11.67
2022-02
0
6.3
2022-03
0
9.54
2022-04
0
8.4
2022-05
0
6.5
2022-06
0
4.48
2022-07
0
4.8
2022-08
0
6.43
2022-09
0
2.92
2022-10
0
6.56
2022-11
0
9.8
2022-12
0
12.5
2023-01
0
6.67
2023-02
0
8.7
2023-03
0
11.08
2023-04
0
9.8
2023-05
0
8.5
2023-06
0
9.2
2023-07
0
8
2023-08
0
12.08
2023-09
0
13.22
2023-10
0
9.75
2023-11
0
7.54
2023-12
0
12.27
2024-01
0
7.33
2024-02
0
11.36
2024-03
0
10.5
2024-04
0
10.42
2024-05
0
11.58
2024-06
0
10.5
2024-07
0
10.82
2024-08
0
10.64
2024-09
0
12
2024-10
0
12
2024-11
0
12.31
2024-12
0
16.73
2025-01
0
14.9
2025-02
0
10.7
2025-03
0
10.58
2025-04
0
10.42
2025-05
0
18.58
2025-06
0
12.17
2025-07
0
8.82
2025-08
0
11.7
2025-09
0
6.77
2025-10
0
9.89
2025-11
0
14.8
2025-12
0
18
2026-01
0
13
2026-02
0
9.85
2026-03
0
12.4
2026-04
0
10.4
2026-05
0
7.09
2026-06
0
10.7
This device (reports/month)Average device in PKL (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K172727 — cites (transitively): K122660 (d1), K161463 (d1), K152001 (d2) — cited as predicate by K231633, K232450, K241005
Lineage extracted from public 510(k) summary text (heuristic).