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"2dsl7 8-0 Bl V Silk 18""/45 Cm"
Model DA-2550N · Surgical Specialties México, S. de R.L. de C.V. · DI 00848782013555
GAP — Suture, Nonabsorbable, Silk · Class II · 21 CFR 878.5030
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
3.4
2019-02
0
5.4
2019-03
0
3.25
2019-04
0
2.29
2019-05
0
1
2019-06
0
4
2019-07
0
2.4
2019-08
0
2
2019-09
0
1.5
2019-10
0
1.86
2019-11
0
4.63
2019-12
0
1.82
2020-01
0
3.36
2020-02
0
3
2020-03
0
3.5
2020-04
0
3.56
2020-05
0
2
2020-06
0
2
2020-07
0
2.67
2020-08
0
1
2020-09
0
1
2020-10
0
3.71
2020-11
0
2.33
2020-12
0
3.25
2021-01
0
5
2021-02
0
12.6
2021-03
0
5.2
2021-04
0
3
2021-05
0
2
2021-06
0
3.17
2021-07
0
1.2
2021-08
0
3.5
2021-09
0
2.33
2021-10
0
4.33
2021-11
0
2.5
2021-12
0
5.25
2022-01
0
2
2022-02
0
5.5
2022-03
0
1.67
2022-04
0
9.4
2022-05
0
3.81
2022-06
0
3.78
2022-07
0
4.38
2022-08
0
3.25
2022-09
0
2.38
2022-10
0
4.17
2022-11
0
14.08
2022-12
0
7.18
2023-01
0
12.15
2023-02
0
13.25
2023-03
0
14.4
2023-04
0
16.67
2023-05
0
15.08
2023-06
0
13.33
2023-07
0
21.67
2023-08
0
30.2
2023-09
0
14.7
2023-10
0
14.86
2023-11
0
7.63
2023-12
0
16.57
2024-01
0
10.86
2024-02
0
20
2024-03
0
55.42
2024-04
0
86.94
2024-05
0
152.45
2024-06
0
112
2024-07
0
122.82
2024-08
0
41.77
2024-09
0
29.44
2024-10
0
18.33
2024-11
0
12.5
2024-12
0
5.56
2025-01
0
1.64
2025-02
0
1.42
2025-03
0
1.77
2025-04
0
2
2025-05
0
4.2
2025-06
0
4.25
2025-07
0
1.54
2025-08
0
1.9
2025-09
0
1.31
2025-10
0
1.8
2025-11
0
4.67
2025-12
0
2.45
2026-01
0
2.88
2026-02
0
2.33
2026-03
0
1.58
2026-04
0
3.86
2026-05
0
3.47
2026-06
0
1.67
This device (reports/month)Average device in GAP (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Surgical Specialties México, S. de R.L. de C.V.