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AMI Custom Crafted FCN 19G x 90mm
Model W-FTN1991G · Feeltech Co.,Ltd. · DI 18809407788486
NEW — Suture, Surgical, Absorbable, Polydioxanone · Class II · 21 CFR 878.4840
UDILibrary device dossier · generated 2026-09-11 · 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
4.18
2019-02
0
2.48
2019-03
0
3.54
2019-04
0
3.12
2019-05
0
3.19
2019-06
0
4.56
2019-07
0
4.03
2019-08
0
5.55
2019-09
0
4.09
2019-10
0
4.03
2019-11
0
5.94
2019-12
0
5.47
2020-01
0
5.78
2020-02
0
5.2
2020-03
0
4.75
2020-04
0
7.45
2020-05
0
7.06
2020-06
0
7.56
2020-07
0
6.17
2020-08
0
5.53
2020-09
0
5.07
2020-10
0
5.14
2020-11
0
7
2020-12
0
8.5
2021-01
0
5.84
2021-02
0
7.33
2021-03
0
7.56
2021-04
0
6.31
2021-05
0
6.63
2021-06
0
5.23
2021-07
0
6.64
2021-08
0
5.75
2021-09
0
5.38
2021-10
0
5.65
2021-11
0
6.71
2021-12
0
7.82
2022-01
0
5.85
2022-02
0
4.56
2022-03
0
7.18
2022-04
0
6.21
2022-05
0
6.89
2022-06
0
5.98
2022-07
0
6.64
2022-08
0
9.75
2022-09
0
7.4
2022-10
0
8.5
2022-11
0
6.91
2022-12
0
8.67
2023-01
0
6.5
2023-02
0
5.85
2023-03
0
7.02
2023-04
0
8.19
2023-05
0
8.57
2023-06
0
8.02
2023-07
0
7.81
2023-08
0
5.03
2023-09
0
5.25
2023-10
0
6.92
2023-11
0
4.28
2023-12
0
5.63
2024-01
0
5.24
2024-02
0
4.69
2024-03
0
4.25
2024-04
0
4.75
2024-05
0
6.72
2024-06
0
4.97
2024-07
0
4.94
2024-08
0
4.38
2024-09
0
5.49
2024-10
0
4.85
2024-11
0
6.06
2024-12
0
5.67
2025-01
0
6.31
2025-02
0
4.47
2025-03
0
6.85
2025-04
0
6.03
2025-05
0
6.13
2025-06
0
5.29
2025-07
0
4.2
2025-08
0
6.77
2025-09
0
3.34
2025-10
0
4.5
2025-11
0
5.45
2025-12
0
5.18
2026-01
0
7
2026-02
0
5.18
2026-03
0
5.57
2026-04
0
6.22
2026-05
0
5.52
2026-06
0
5.7
This device (reports/month)Average device in NEW (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K172602 — cites (transitively): K133420 (d1) — cited as predicate by K190245, K220549, K240389, K250107, K251414
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Feeltech Co.,Ltd.