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Sterile Disposable Button Cannula, 100 mm length
Model KK100L50S · Pemax Kunststoff GmbH · DI 04260462742887
GBX — Catheter, Irrigation · Class I · 21 CFR 878.4200
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
1.83
2019-02
0
2.36
2019-03
0
1.67
2019-04
0
2.08
2019-05
0
1.82
2019-06
0
1.92
2019-07
0
2.21
2019-08
0
2
2019-09
0
2.14
2019-10
0
2.8
2019-11
0
2.67
2019-12
0
1.82
2020-01
0
2.24
2020-02
0
2.45
2020-03
0
1.58
2020-04
0
3.08
2020-05
0
3
2020-06
0
2.14
2020-07
0
2.33
2020-08
0
2.75
2020-09
0
2
2020-10
0
3.08
2020-11
0
3.08
2020-12
0
3.43
2021-01
0
1.78
2021-02
0
2.21
2021-03
0
3.43
2021-04
0
2.71
2021-05
0
2.8
2021-06
0
3.56
2021-07
0
3.57
2021-08
0
3.87
2021-09
0
2.5
2021-10
0
3
2021-11
0
2.9
2021-12
0
5.12
2022-01
0
2.75
2022-02
0
4.89
2022-03
0
5
2022-04
0
2.45
2022-05
0
2.08
2022-06
0
2.47
2022-07
0
2.53
2022-08
0
2.79
2022-09
0
5.21
2022-10
0
3.72
2022-11
0
7.1
2022-12
0
3.67
2023-01
0
2.83
2023-02
0
1.53
2023-03
0
5.33
2023-04
0
2.62
2023-05
0
5.13
2023-06
0
3.07
2023-07
0
4.25
2023-08
0
4.4
2023-09
0
6
2023-10
0
4.21
2023-11
0
3.47
2023-12
0
3.76
2024-01
0
2.86
2024-02
0
4.11
2024-03
0
3.43
2024-04
0
2.57
2024-05
0
4.3
2024-06
0
6.24
2024-07
0
10.05
2024-08
0
4.57
2024-09
0
5.06
2024-10
0
2.75
2024-11
0
4.17
2024-12
0
3.84
2025-01
0
4.45
2025-02
0
3.37
2025-03
0
7.28
2025-04
0
5.63
2025-05
0
3.61
2025-06
0
5.48
2025-07
0
7.56
2025-08
0
8.14
2025-09
0
4.84
2025-10
0
5.74
2025-11
0
3.91
2025-12
0
4.83
2026-01
0
6.83
2026-02
0
6.9
2026-03
0
5.46
2026-04
0
10.25
2026-05
0
4.11
2026-06
0
6.33
This device (reports/month)Average device in GBX (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Pemax Kunststoff GmbH