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AESCULAP
Model FC810R · Aesculap AG · DI 04046964824722
KNS — Unit, Electrosurgical, Endoscopic (With Or Without Accessories) · Class II · 21 CFR 876.4300
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
3.37
2019-02
0
4.38
2019-03
0
4.15
2019-04
0
4.29
2019-05
0
3.84
2019-06
0
3.72
2019-07
0
4.41
2019-08
0
3.59
2019-09
0
4.32
2019-10
0
4.39
2019-11
0
3.67
2019-12
0
3.62
2020-01
0
2.86
2020-02
0
3.79
2020-03
0
3.74
2020-04
0
3.24
2020-05
0
2.57
2020-06
0
3.29
2020-07
0
5.71
2020-08
0
3.2
2020-09
0
4.62
2020-10
0
3.92
2020-11
0
3.26
2020-12
0
4.62
2021-01
0
2.95
2021-02
0
3.77
2021-03
0
4.07
2021-04
0
3.45
2021-05
0
3.44
2021-06
0
4.59
2021-07
0
4.18
2021-08
0
2.36
2021-09
0
3.25
2021-10
0
3.85
2021-11
0
3.3
2021-12
0
3.93
2022-01
0
3.67
2022-02
0
3.36
2022-03
0
3.33
2022-04
0
4.23
2022-05
0
3.17
2022-06
0
4.79
2022-07
0
2.49
2022-08
0
2.61
2022-09
0
2.91
2022-10
0
3.19
2022-11
0
3.08
2022-12
0
2.51
2023-01
0
2.77
2023-02
0
2.22
2023-03
0
2.52
2023-04
0
2.62
2023-05
0
2.72
2023-06
0
2.82
2023-07
0
2.67
2023-08
0
2.5
2023-09
0
3.04
2023-10
0
3.28
2023-11
0
2.96
2023-12
0
2.85
2024-01
0
3.78
2024-02
0
4.16
2024-03
0
3.61
2024-04
0
3.35
2024-05
0
3.53
2024-06
0
2.79
2024-07
0
2.68
2024-08
0
3.96
2024-09
0
3.45
2024-10
0
2.82
2024-11
0
4.42
2024-12
0
5.21
2025-01
0
2.68
2025-02
0
3.31
2025-03
0
2.8
2025-04
0
2.42
2025-05
0
5.34
2025-06
0
3.09
2025-07
0
3.17
2025-08
0
2.9
2025-09
0
4.47
2025-10
0
6.61
2025-11
0
4.13
2025-12
0
3.64
2026-01
0
3.62
2026-02
0
3.21
2026-03
0
4.48
2026-04
0
4.46
2026-05
0
8.03
2026-06
0
3.67
This device (reports/month)Average device in KNS (reports/device/month)