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ABC Dilatation Balloon Catheter
Model FWB-06/80-6/18-S · Micro-Tech (Nanjing) Co., Ltd. · DI 46932503524078
KNQ — Dilator, Esophageal · Class II · 21 CFR 876.5365
UDILibrary device dossier · generated 2026-09-14 · 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
2019-02
0
1.94
2019-03
0
2.37
2019-04
0
2.44
2019-05
0
2.5
2019-06
0
2.75
2019-07
0
2.72
2019-08
0
2.47
2019-09
0
2.11
2019-10
0
2.71
2019-11
0
2.79
2019-12
0
2.67
2020-01
0
2
2020-02
0
2.89
2020-03
0
3.33
2020-04
0
3
2020-05
0
2.2
2020-06
0
2.45
2020-07
0
3.67
2020-08
0
4.3
2020-09
0
3
2020-10
0
3.46
2020-11
0
2.9
2020-12
0
3.1
2021-01
0
3.33
2021-02
0
2.25
2021-03
0
5.83
2021-04
0
4.22
2021-05
0
6.44
2021-06
0
7.1
2021-07
0
8.63
2021-08
0
3.91
2021-09
0
3.5
2021-10
0
3.4
2021-11
0
4.3
2021-12
0
2
2022-01
0
2
2022-02
0
1.8
2022-03
0
2.63
2022-04
0
2
2022-05
0
2.69
2022-06
0
2.75
2022-07
0
2.22
2022-08
0
2.75
2022-09
0
2.44
2022-10
0
2.8
2022-11
0
4.77
2022-12
0
3.44
2023-01
0
4.2
2023-02
0
1.78
2023-03
0
2.18
2023-04
0
2.7
2023-05
0
2.38
2023-06
0
4.09
2023-07
0
8.25
2023-08
0
4.2
2023-09
0
3
2023-10
0
3.44
2023-11
0
4.43
2023-12
0
2.7
2024-01
0
2.78
2024-02
0
2.78
2024-03
0
2.3
2024-04
0
3.2
2024-05
0
1.71
2024-06
0
2.67
2024-07
0
2
2024-08
0
2.71
2024-09
0
3.92
2024-10
0
3.18
2024-11
0
5
2024-12
0
3.18
2025-01
0
2.71
2025-02
0
2.5
2025-03
0
1.78
2025-04
0
1.71
2025-05
0
2.91
2025-06
0
1.73
2025-07
0
4.15
2025-08
0
2.64
2025-09
0
3.6
2025-10
0
3.75
2025-11
0
4.38
2025-12
0
3.31
2026-01
0
2.83
2026-02
0
3.91
2026-03
0
2.6
2026-04
0
3.5
2026-05
0
5.3
2026-06
0
4
This device (reports/month)Average device in KNQ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
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