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VS3-NE
Model 153-0002 · VISIONSENSE LTD. · DI 18130400103045
GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500
GWG — Endoscope, Neurological · Class II · 21 CFR 882.1480
UDILibrary device dossier · generated 2026-09-15 · 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
3.53
2019-03
0
2.93
2019-04
0
3.09
2019-05
0
2.45
2019-06
0
3.52
2019-07
0
2.42
2019-08
0
2.45
2019-09
0
2.45
2019-10
0
2.71
2019-11
0
2.12
2019-12
0
2.35
2020-01
0
2.55
2020-02
0
2.71
2020-03
0
2.29
2020-04
0
2.54
2020-05
0
1.98
2020-06
0
2.78
2020-07
0
2.77
2020-08
0
4.29
2020-09
0
4.4
2020-10
0
3.95
2020-11
0
4.44
2020-12
0
3.83
2021-01
0
3.99
2021-02
0
3.89
2021-03
0
4.74
2021-04
0
4.65
2021-05
0
4.08
2021-06
0
4.28
2021-07
0
3.86
2021-08
0
3.85
2021-09
0
3.89
2021-10
0
3.97
2021-11
0
3.48
2021-12
0
4.44
2022-01
0
4.57
2022-02
0
5.03
2022-03
0
5.45
2022-04
0
6.39
2022-05
0
5.46
2022-06
0
6.03
2022-07
0
6.34
2022-08
0
6.3
2022-09
0
5.47
2022-10
0
5.32
2022-11
0
5.49
2022-12
0
6
2023-01
0
5.67
2023-02
0
4.79
2023-03
0
5.84
2023-04
0
5.45
2023-05
0
5.81
2023-06
0
7.04
2023-07
0
6.02
2023-08
0
6.25
2023-09
0
5.86
2023-10
0
6.33
2023-11
0
5.7
2023-12
0
6.05
2024-01
0
5.43
2024-02
0
6.16
2024-03
0
5.52
2024-04
0
6.29
2024-05
0
5.28
2024-06
0
6.99
2024-07
0
5.72
2024-08
0
6.5
2024-09
0
6.2
2024-10
0
7.08
2024-11
0
4.53
2024-12
0
4.77
2025-01
0
4.38
2025-02
0
3.98
2025-03
0
5.14
2025-04
0
4.62
2025-05
0
4.59
2025-06
0
4.48
2025-07
0
4.66
2025-08
0
5.44
2025-09
0
3.89
2025-10
0
4.43
2025-11
0
4.78
2025-12
0
5.94
2026-01
0
4.89
2026-02
0
4.95
2026-03
0
5.55
2026-04
0
6.14
2026-05
0
5.77
2026-06
0
4.89
This device (reports/month)Average device in GCJ, GWG (reports/device/month)
Regulatory clearances
K131434 SESE 2013-07-16 (k number procode)
K123467 SESE 2013-04-17 (k number procode)
Predicate lineage
K123467 — cites (transitively): K073279 (d1) — cited as predicate by K150018, K152204, K191851
K131434 — cites (transitively): K081102 (d1) — cited as predicate by K141002, K150018, K152204, K162880, K191851
Lineage extracted from public 510(k) summary text (heuristic).