Model EUS-22-0-F · Micro-Tech (Nanjing) Co., Ltd. · DI 06932503534642
FCG — Biopsy Needle · Class II · 21 CFR 876.1075
ODG — Endoscopic Ultrasound System, Gastroenterology-Urology · Class II · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-15 · 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
2.28
2019-02
0
3.62
2019-03
0
3.06
2019-04
0
2.95
2019-05
0
3.07
2019-06
0
4.81
2019-07
0
4
2019-08
0
3.93
2019-09
0
3.05
2019-10
0
3.33
2019-11
0
2.83
2019-12
0
2.78
2020-01
0
2.44
2020-02
0
3.2
2020-03
0
2.21
2020-04
0
2.47
2020-05
0
2.2
2020-06
0
2.81
2020-07
0
2.89
2020-08
0
2.53
2020-09
0
1.73
2020-10
0
5.04
2020-11
0
4.44
2020-12
0
6.7
2021-01
0
7.4
2021-02
0
4.53
2021-03
0
6.52
2021-04
0
4.84
2021-05
0
6.61
2021-06
0
8.08
2021-07
0
6.86
2021-08
0
6.06
2021-09
0
7.21
2021-10
0
5.75
2021-11
0
5.5
2021-12
0
8.15
2022-01
0
6.03
2022-02
0
6.3
2022-03
0
5
2022-04
0
7.24
2022-05
0
8.17
2022-06
0
6.32
2022-07
0
7.45
2022-08
0
4.54
2022-09
0
4.33
2022-10
0
4.23
2022-11
0
4.21
2022-12
0
5.88
2023-01
0
4.58
2023-02
0
4.48
2023-03
0
5.33
2023-04
0
3.83
2023-05
0
4.55
2023-06
0
4.16
2023-07
0
3.89
2023-08
0
3.92
2023-09
0
4.75
2023-10
0
5.21
2023-11
0
4.11
2023-12
0
4.26
2024-01
0
5.1
2024-02
0
3.81
2024-03
0
3.85
2024-04
0
3.91
2024-05
0
4.42
2024-06
0
5.19
2024-07
0
3.92
2024-08
0
6.67
2024-09
0
3.33
2024-10
0
4.91
2024-11
0
3.19
2024-12
0
3.08
2025-01
0
4.96
2025-02
0
3.31
2025-03
0
3.03
2025-04
0
4.38
2025-05
0
3.03
2025-06
0
4.96
2025-07
0
3.21
2025-08
0
4.68
2025-09
0
6.29
2025-10
0
10.59
2025-11
0
18.89
2025-12
0
24.25
2026-01
0
19.22
2026-02
0
10.89
2026-03
0
8.37
2026-04
0
12.95
2026-05
0
18.81
2026-06
0
13.59
This device (reports/month)Average device in FCG, ODG (reports/device/month)