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AESCULAP
Model GP495R · Aesculap AG · DI 04046964643033
GEY — Motor, Surgical Instrument, Ac-Powered · Class I · 21 CFR 878.4820
HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered) · Class II · 21 CFR 882.4310
UDILibrary device dossier · generated 2026-09-06 · 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
2.42
2019-02
0
5.19
2019-03
0
7.96
2019-04
0
4.55
2019-05
0
6
2019-06
0
5.73
2019-07
0
4.42
2019-08
0
6.63
2019-09
0
4.76
2019-10
0
4.69
2019-11
0
5.27
2019-12
0
6.2
2020-01
0
4.42
2020-02
0
8.12
2020-03
0
7.96
2020-04
0
4.04
2020-05
0
4.03
2020-06
0
6.16
2020-07
0
4.69
2020-08
0
4.24
2020-09
0
6.32
2020-10
0
4.75
2020-11
0
6.17
2020-12
0
6.63
2021-01
0
4.75
2021-02
0
4.48
2021-03
0
5.2
2021-04
0
3.88
2021-05
0
3.82
2021-06
0
5.91
2021-07
0
4.23
2021-08
0
6.23
2021-09
0
5.76
2021-10
0
3.85
2021-11
0
4.53
2021-12
0
7.07
2022-01
0
3.84
2022-02
0
5.66
2022-03
0
6.19
2022-04
0
3.71
2022-05
0
4.56
2022-06
0
5.89
2022-07
0
4.65
2022-08
0
5.74
2022-09
0
5.92
2022-10
0
4.25
2022-11
0
5.18
2022-12
0
7.48
2023-01
0
4.03
2023-02
0
5.27
2023-03
0
5.16
2023-04
0
4.37
2023-05
0
7.24
2023-06
0
6.18
2023-07
0
4.16
2023-08
0
5.16
2023-09
0
5.44
2023-10
0
3.51
2023-11
0
6.25
2023-12
0
3.91
2024-01
0
4.11
2024-02
0
4.49
2024-03
0
4.81
2024-04
0
3.77
2024-05
0
3.6
2024-06
0
5.47
2024-07
0
3.44
2024-08
0
3.54
2024-09
0
4.24
2024-10
0
3.58
2024-11
0
3.14
2024-12
0
4.44
2025-01
0
3.29
2025-02
0
4.29
2025-03
0
2.98
2025-04
0
2.47
2025-05
0
3.31
2025-06
0
3.8
2025-07
0
3.23
2025-08
0
2.95
2025-09
0
3.06
2025-10
0
3.01
2025-11
0
3.91
2025-12
0
4.26
2026-01
0
2.92
2026-02
0
3.2
2026-03
0
4.62
2026-04
0
4.81
2026-05
0
5.13
2026-06
0
14.69
This device (reports/month)Average device in GEY, HBE (reports/device/month)