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ATA-CUT
Model ATA-CUT · STERYLAB SRL · DI 08033959222430
FCG — Biopsy Needle · Class II · 21 CFR 876.1075
KNW — Instrument, Biopsy · Class II · 21 CFR 876.1075
UDILibrary device dossier · generated 2026-09-07 · 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
6.93
2019-02
0
4.45
2019-03
0
3.04
2019-04
0
3.39
2019-05
0
6.14
2019-06
0
25.57
2019-07
0
7.84
2019-08
0
34.96
2019-09
0
18.07
2019-10
0
9.18
2019-11
0
21.95
2019-12
0
27.54
2020-01
0
29.5
2020-02
0
18.74
2020-03
0
60.38
2020-04
0
46
2020-05
0
14.14
2020-06
0
41.62
2020-07
0
28.96
2020-08
0
17.63
2020-09
0
21.97
2020-10
0
16.07
2020-11
0
21.9
2020-12
0
9.68
2021-01
0
12.68
2021-02
0
9.27
2021-03
0
8.82
2021-04
0
6.49
2021-05
0
3.42
2021-06
0
3.95
2021-07
0
4.3
2021-08
0
4.38
2021-09
0
7.22
2021-10
0
4
2021-11
0
3.29
2021-12
0
4.64
2022-01
0
5.19
2022-02
0
5.08
2022-03
0
3.63
2022-04
0
3.02
2022-05
0
2.62
2022-06
0
2.31
2022-07
0
3.15
2022-08
0
3.21
2022-09
0
4.12
2022-10
0
4.38
2022-11
0
3.35
2022-12
0
4.66
2023-01
0
3.03
2023-02
0
5
2023-03
0
4.65
2023-04
0
4.6
2023-05
0
4.33
2023-06
0
4.77
2023-07
0
3.73
2023-08
0
3.61
2023-09
0
3.89
2023-10
0
6.64
2023-11
0
5.15
2023-12
0
5.89
2024-01
0
7.41
2024-02
0
4.06
2024-03
0
3.11
2024-04
0
5.32
2024-05
0
4.49
2024-06
0
8.24
2024-07
0
4.45
2024-08
0
7.9
2024-09
0
8.9
2024-10
0
4.76
2024-11
0
3.46
2024-12
0
4.67
2025-01
0
5.14
2025-02
0
5.58
2025-03
0
6.78
2025-04
0
7.62
2025-05
0
6.02
2025-06
0
6.31
2025-07
0
4.85
2025-08
0
8.02
2025-09
0
5.75
2025-10
0
5.33
2025-11
0
6.46
2025-12
0
7.17
2026-01
0
11.55
2026-02
0
13.58
2026-03
0
8.19
2026-04
0
9.69
2026-05
0
11.89
2026-06
0
12.33
This device (reports/month)Average device in FCG, KNW (reports/device/month)