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Single-use Broncho Videoscope
Model SBV-1C-B · Scivita Medical Technology Co., Ltd. · DI 06971381254716
EOQ — Bronchoscope (Flexible Or Rigid) · Class II · 21 CFR 874.4680
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
1.2
2019-02
0
1.5
2019-03
0
6.89
2019-04
0
44.75
2019-05
0
4
2019-06
0
3
2019-07
0
2.54
2019-08
0
4.78
2019-09
0
2.78
2019-10
0
2.57
2019-11
0
2.4
2019-12
0
4.25
2020-01
0
2.92
2020-02
0
6.2
2020-03
0
2.33
2020-04
0
4.31
2020-05
0
2.93
2020-06
0
4.24
2020-07
0
4.65
2020-08
0
4.5
2020-09
0
3.76
2020-10
0
3.91
2020-11
0
4.52
2020-12
0
6.57
2021-01
0
4.39
2021-02
0
4.04
2021-03
0
5.57
2021-04
0
4.75
2021-05
0
5.1
2021-06
0
4.02
2021-07
0
3.22
2021-08
0
4.9
2021-09
0
4.18
2021-10
0
4.75
2021-11
0
3.93
2021-12
0
4.87
2022-01
0
4.98
2022-02
0
4.54
2022-03
0
6.65
2022-04
0
6.56
2022-05
0
5.72
2022-06
0
6.05
2022-07
0
6.22
2022-08
0
5.78
2022-09
0
5.19
2022-10
0
5.56
2022-11
0
5.65
2022-12
0
5.77
2023-01
0
8
2023-02
0
5.67
2023-03
0
7.22
2023-04
0
5.99
2023-05
0
6.6
2023-06
0
6.31
2023-07
0
6.17
2023-08
0
7.54
2023-09
0
6.8
2023-10
0
6.71
2023-11
0
7.17
2023-12
0
7.04
2024-01
0
6.36
2024-02
0
6.05
2024-03
0
7.21
2024-04
0
6.19
2024-05
0
6.2
2024-06
0
7.13
2024-07
0
6.06
2024-08
0
7.7
2024-09
0
6.97
2024-10
0
8.15
2024-11
0
10.86
2024-12
0
4.17
2025-01
0
4.16
2025-02
0
3.73
2025-03
0
4.21
2025-04
0
4.31
2025-05
0
4.93
2025-06
0
4.86
2025-07
0
5.79
2025-08
0
5.13
2025-09
0
4.38
2025-10
0
5.19
2025-11
0
6.62
2025-12
0
10.31
2026-01
0
8.47
2026-02
0
6.48
2026-03
0
6.61
2026-04
0
8.85
2026-05
0
9.34
2026-06
0
8.3
This device (reports/month)Average device in EOQ (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