Print-ready dossier — use your browser's print dialog to save as PDF.
Disposable Distal Cap
Model VC23037 · Micro-Tech (Nanjing) Co., Ltd. · DI 06932503563529
FDS — Gastroscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-13 · 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
1.86
2019-02
0
1.8
2019-03
0
1.6
2019-04
0
2.19
2019-05
0
1.75
2019-06
0
2.75
2019-07
0
1.5
2019-08
0
1.95
2019-09
0
2.09
2019-10
0
2.18
2019-11
0
1.58
2019-12
0
2.1
2020-01
0
1.57
2020-02
0
2.18
2020-03
0
2.06
2020-04
0
1.94
2020-05
0
7.06
2020-06
0
2.14
2020-07
0
3.61
2020-08
0
3.36
2020-09
0
3.63
2020-10
0
4.17
2020-11
0
4.26
2020-12
0
7.46
2021-01
0
6.3
2021-02
0
10.32
2021-03
0
7.43
2021-04
0
9.95
2021-05
0
8.13
2021-06
0
6.71
2021-07
0
9.42
2021-08
0
7.93
2021-09
0
9.61
2021-10
0
7.72
2021-11
0
8.9
2021-12
0
10.16
2022-01
0
10.67
2022-02
0
11.81
2022-03
0
12.25
2022-04
0
12.09
2022-05
0
10.7
2022-06
0
11.85
2022-07
0
14.23
2022-08
0
15.76
2022-09
0
12.85
2022-10
0
12.56
2022-11
0
12.48
2022-12
0
12.42
2023-01
0
10.09
2023-02
0
9.86
2023-03
0
13.76
2023-04
0
13.12
2023-05
0
11.67
2023-06
0
12.42
2023-07
0
12.83
2023-08
0
13.91
2023-09
0
11.37
2023-10
0
12.69
2023-11
0
13.1
2023-12
0
11.9
2024-01
0
12.31
2024-02
0
11.91
2024-03
0
14.84
2024-04
0
11.47
2024-05
0
10.23
2024-06
0
10.46
2024-07
0
11.77
2024-08
0
8.91
2024-09
0
8.88
2024-10
0
11.82
2024-11
0
5.52
2024-12
0
5.09
2025-01
0
6.21
2025-02
0
6.42
2025-03
0
7.65
2025-04
0
7.61
2025-05
0
7.62
2025-06
0
9.02
2025-07
0
7.61
2025-08
0
9.16
2025-09
0
6.1
2025-10
0
11.22
2025-11
0
18.97
2025-12
0
35.76
2026-01
0
27.58
2026-02
0
16.65
2026-03
0
16.83
2026-04
0
23.37
2026-05
0
21.92
2026-06
0
22.68
This device (reports/month)Average device in FDS (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K243388 — cites (transitively): K984358 (d1)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Micro-Tech (Nanjing) Co., Ltd.
VAI 2014-06-12 Micro-Tech (Nanjing) Co., Ltd. · 1 citations
VAI 2014-06-12 Micro-Tech (Nanjing) Co., Ltd. · 1 citations