Single-Use Flexible Cystoscope
Model CY-S2E01R · Hunan Vathin Medical Instrument Co., Ltd · DI 06972197483376
FAJ — Cystoscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-07 · 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.
| 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 |
Regulatory clearances
- K242535 SESE 2024-12-18 (k number procode)
Predicate lineage
K242535 — cites (transitively): K193095 (d1), K223299 (d1), K133538 (d2), K160766 (d2), K173727 (d2), K220606 (d2), K062049 (d3), K021074 (d3), K072180 (d3), K130845 (d3), K955066 (d3), K091768 (d3), K161656 (d3), K061313 (d3), K121959 (d3), K051645 (d4), K100584 (d4), K023984 (d4), K110962 (d4), K981543 (d4), K130485 (d4)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Hunan Vathin Medical Instrument Co., Ltd
Nothing in the loaded window.