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"2hsl5 10-0 Bl Ppn 12""/30 Cm"
Model JA-2529N · Surgical Specialties México, S. de R.L. de C.V. · DI 00848782017140
GAW — Suture, Nonabsorbable, Synthetic, Polypropylene · Class II · 21 CFR 878.5010
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
1.36
2019-02
0
1.92
2019-03
0
2.44
2019-04
0
3.42
2019-05
0
3.67
2019-06
0
4.1
2019-07
0
3.22
2019-08
0
5.19
2019-09
0
3.71
2019-10
0
3.97
2019-11
0
3.6
2019-12
0
3.86
2020-01
0
4.07
2020-02
0
4.89
2020-03
0
5.06
2020-04
0
6.61
2020-05
0
7.21
2020-06
0
3.62
2020-07
0
4.44
2020-08
0
4.58
2020-09
0
3.5
2020-10
0
4.89
2020-11
0
5.32
2020-12
0
5.22
2021-01
0
7.89
2021-02
0
6.47
2021-03
0
5.37
2021-04
0
4.2
2021-05
0
3.03
2021-06
0
5.17
2021-07
0
4.94
2021-08
0
5.37
2021-09
0
4.26
2021-10
0
6.04
2021-11
0
4.46
2021-12
0
6.12
2022-01
0
7.52
2022-02
0
4.29
2022-03
0
5.63
2022-04
0
4.23
2022-05
0
6.71
2022-06
0
4.74
2022-07
0
5.13
2022-08
0
6.25
2022-09
0
5.32
2022-10
0
4.1
2022-11
0
5.84
2022-12
0
6.97
2023-01
0
6.08
2023-02
0
6.45
2023-03
0
6.46
2023-04
0
7.96
2023-05
0
6.46
2023-06
0
6.84
2023-07
0
5.93
2023-08
0
3.9
2023-09
0
3.46
2023-10
0
5.2
2023-11
0
6.25
2023-12
0
4.23
2024-01
0
3.83
2024-02
0
3
2024-03
0
4.42
2024-04
0
3.57
2024-05
0
3.5
2024-06
0
4.36
2024-07
0
5.13
2024-08
0
4.42
2024-09
0
5.62
2024-10
0
4.3
2024-11
0
4.57
2024-12
0
4.06
2025-01
0
6.47
2025-02
0
5.39
2025-03
0
3.76
2025-04
0
2.98
2025-05
0
4.7
2025-06
0
6.21
2025-07
0
5.11
2025-08
0
4.96
2025-09
0
4.63
2025-10
0
4.66
2025-11
0
6.5
2025-12
0
6.31
2026-01
0
5.96
2026-02
0
4.19
2026-03
0
5.76
2026-04
0
5.25
2026-05
0
6.86
2026-06
0
6.26
This device (reports/month)Average device in GAW (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Surgical Specialties México, S. de R.L. de C.V.