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Single-Use Flexible Cystoscope
Model CY-S1D01R · Hunan Vathin Medical Instrument Co., Ltd · DI 06972197483215
FAJ — Cystoscope And Accessories, Flexible/Rigid · 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)
2019-02
0
2
2019-03
0
1
2019-05
0
2
2019-08
0
3
2019-09
0
4
2019-10
0
2
2019-12
0
1
2020-02
0
1
2020-04
0
2.5
2020-06
0
1.33
2020-07
0
2.5
2020-08
0
1.33
2020-09
0
2.25
2020-10
0
2
2020-11
0
2
2020-12
0
5.67
2021-01
0
3.75
2021-02
0
10.43
2021-03
0
4
2021-04
0
2.33
2021-05
0
2.6
2021-06
0
3.8
2021-07
0
3.44
2021-08
0
3
2021-09
0
3.5
2021-10
0
3.5
2021-11
0
4
2021-12
0
4.5
2022-01
0
3.33
2022-02
0
3
2022-03
0
4
2022-04
0
3.33
2022-05
0
3
2022-06
0
3
2022-07
0
3.44
2022-08
0
2.5
2022-09
0
3.4
2022-10
0
4
2022-11
0
3.36
2022-12
0
2.9
2023-01
0
2.7
2023-02
0
2.77
2023-03
0
2.44
2023-04
0
4
2023-05
0
2.55
2023-06
0
3.42
2023-07
0
3.08
2023-08
0
2.67
2023-09
0
2.38
2023-10
0
3.75
2023-11
0
3.5
2023-12
0
7.82
2024-01
0
5.67
2024-02
0
7.1
2024-03
0
7.2
2024-04
0
3.4
2024-05
0
2.17
2024-06
0
3.42
2024-07
0
3.42
2024-08
0
4.42
2024-09
0
2.4
2024-10
0
3.67
2024-11
0
2.18
2024-12
0
1
2025-01
0
1.82
2025-02
0
3.09
2025-03
0
2.38
2025-04
0
2.43
2025-05
0
3.36
2025-06
0
2.91
2025-07
0
4
2025-08
0
5.85
2025-09
0
6.22
2025-10
0
36.23
2025-11
0
13.06
2025-12
0
4.82
2026-01
0
10.87
2026-02
0
8.38
2026-03
0
5.27
2026-04
0
16.2
2026-05
0
11.9
2026-06
0
12.06
This device (reports/month)Average device in FAJ (reports/device/month)