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Power Cord for VS3 Cart - Brazil
Model VS3 · VISIONSENSE LTD. · DI 10813040013865
GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500
GWG — Endoscope, Neurological · Class II · 21 CFR 882.1480
HRX — Arthroscope · Class II · 21 CFR 888.1100
OWN — Confocal Optical Imaging · Class II · 21 CFR 876.1500
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
6.91
2019-02
0
3.45
2019-03
0
3.19
2019-04
0
3.47
2019-05
0
3.05
2019-06
0
3.54
2019-07
0
2.7
2019-08
0
2.97
2019-09
0
3.15
2019-10
0
3.5
2019-11
0
3.03
2019-12
0
3.18
2020-01
0
3.41
2020-02
0
3.56
2020-03
0
3.29
2020-04
0
3.35
2020-05
0
2.73
2020-06
0
3.78
2020-07
0
3.62
2020-08
0
4.69
2020-09
0
5.54
2020-10
0
5.51
2020-11
0
4.9
2020-12
0
5.64
2021-01
0
4.77
2021-02
0
4.51
2021-03
0
5.89
2021-04
0
5.26
2021-05
0
4.6
2021-06
0
4.7
2021-07
0
4.19
2021-08
0
4.2
2021-09
0
3.76
2021-10
0
4.29
2021-11
0
3.56
2021-12
0
4.77
2022-01
0
4.63
2022-02
0
4.78
2022-03
0
5.18
2022-04
0
5.65
2022-05
0
5.44
2022-06
0
5.61
2022-07
0
5.76
2022-08
0
5.6
2022-09
0
4.95
2022-10
0
4.96
2022-11
0
5.24
2022-12
0
5.58
2023-01
0
5.51
2023-02
0
4.67
2023-03
0
5.69
2023-04
0
5.35
2023-05
0
5.64
2023-06
0
6.11
2023-07
0
5.47
2023-08
0
5.99
2023-09
0
5.71
2023-10
0
5.79
2023-11
0
6.4
2023-12
0
7
2024-01
0
5.8
2024-02
0
6.62
2024-03
0
5.71
2024-04
0
6.4
2024-05
0
6.37
2024-06
0
7.88
2024-07
0
5.9
2024-08
0
6.34
2024-09
0
5.97
2024-10
0
7.03
2024-11
0
4.8
2024-12
0
5.82
2025-01
0
5.69
2025-02
0
4.6
2025-03
0
5.13
2025-04
0
4.83
2025-05
0
4.96
2025-06
0
4.69
2025-07
0
4.92
2025-08
0
5.07
2025-09
0
4.11
2025-10
0
4.61
2025-11
0
4.95
2025-12
0
5.88
2026-01
0
5.06
2026-02
0
5.03
2026-03
0
5.46
2026-04
0
6.37
2026-05
0
5.35
2026-06
0
4.81
This device (reports/month)Average device in GCJ, GWG, HRX, OWN (reports/device/month)
Regulatory clearances
K183453 SESE 2019-03-04 (k number procode)
Predicate lineage
K183453 — cited as predicate by K191851, K210265, K223020
Lineage extracted from public 510(k) summary text (heuristic).