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4K UHD Laparoscope
Model 4K5500R · Scivita Medical Technology Co., Ltd. · DI 06971381250220
GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500
HET — Laparoscope, Gynecologic (And Accessories) · Class II · 21 CFR 884.1720
NMH — Laparoscope And Accessories, Gynecologic, Reprocessed · Class II · 21 CFR 884.1720
UDILibrary device dossier · generated 2026-09-16 · 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
2.43
2019-02
0
3.51
2019-03
0
2.93
2019-04
0
3.05
2019-05
0
2.43
2019-06
0
3.47
2019-07
0
2.39
2019-08
0
2.46
2019-09
0
2.44
2019-10
0
2.63
2019-11
0
2.09
2019-12
0
2.39
2020-01
0
2.52
2020-02
0
2.61
2020-03
0
2.29
2020-04
0
2.67
2020-05
0
2.07
2020-06
0
2.94
2020-07
0
2.97
2020-08
0
4.49
2020-09
0
4.48
2020-10
0
4.2
2020-11
0
4.89
2020-12
0
4.26
2021-01
0
4.25
2021-02
0
4.11
2021-03
0
5.32
2021-04
0
5.3
2021-05
0
4.65
2021-06
0
4.81
2021-07
0
4.16
2021-08
0
4.26
2021-09
0
4.34
2021-10
0
4.38
2021-11
0
3.77
2021-12
0
5.07
2022-01
0
5.65
2022-02
0
6.64
2022-03
0
6.91
2022-04
0
8.13
2022-05
0
6.75
2022-06
0
7.83
2022-07
0
8.06
2022-08
0
7.93
2022-09
0
6.85
2022-10
0
6.52
2022-11
0
6.9
2022-12
0
8.74
2023-01
0
8.38
2023-02
0
6.35
2023-03
0
8.43
2023-04
0
7.18
2023-05
0
7.55
2023-06
0
8.77
2023-07
0
7.75
2023-08
0
7.83
2023-09
0
7.85
2023-10
0
7.98
2023-11
0
7.67
2023-12
0
7.51
2024-01
0
6.95
2024-02
0
7.33
2024-03
0
7.06
2024-04
0
9.02
2024-05
0
9.82
2024-06
0
12.93
2024-07
0
11.19
2024-08
0
10.99
2024-09
0
11.47
2024-10
0
12.31
2024-11
0
7.7
2024-12
0
9.64
2025-01
0
9.94
2025-02
0
9.22
2025-03
0
9.64
2025-04
0
8.75
2025-05
0
8.5
2025-06
0
8.09
2025-07
0
8.43
2025-08
0
10.24
2025-09
0
7.63
2025-10
0
9.27
2025-11
0
10.27
2025-12
0
14.39
2026-01
0
9.3
2026-02
0
10.29
2026-03
0
13.53
2026-04
0
13.09
2026-05
0
12
2026-06
0
8.97
This device (reports/month)Average device in GCJ, HET, NMH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Scivita Medical Technology Co., Ltd.
VAI 2025-04-10 SCIVITA MEDICAL TECHNOLOGY CO LTD · 0 citations
VAI 2025-04-10 SCIVITA MEDICAL TECHNOLOGY CO LTD · 0 citations