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ADVANTIME
Model 15S10X · PETERS SURGICAL · DI 03661522100691
GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid · Class II · 21 CFR 878.4493
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
2.98
2019-02
0
3.09
2019-03
0
2.24
2019-04
0
2.67
2019-05
0
3.29
2019-06
0
3.11
2019-07
0
2.78
2019-08
0
2.72
2019-09
0
3.03
2019-10
0
2.5
2019-11
0
2.97
2019-12
0
2.85
2020-01
0
3.37
2020-02
0
3.37
2020-03
0
3.43
2020-04
0
4.75
2020-05
0
3.63
2020-06
0
2.6
2020-07
0
5.16
2020-08
0
3.19
2020-09
0
4.29
2020-10
0
3.95
2020-11
0
2.99
2020-12
0
4.34
2021-01
0
4.87
2021-02
0
4.23
2021-03
0
4.09
2021-04
0
3.76
2021-05
0
4.65
2021-06
0
3.65
2021-07
0
4.98
2021-08
0
4.09
2021-09
0
4.92
2021-10
0
3.65
2021-11
0
3.53
2021-12
0
4.93
2022-01
0
3.86
2022-02
0
3.4
2022-03
0
4.44
2022-04
0
4.56
2022-05
0
4.23
2022-06
0
3.81
2022-07
0
4.06
2022-08
0
5.99
2022-09
0
6.05
2022-10
0
4.33
2022-11
0
5.24
2022-12
0
6.06
2023-01
0
4.36
2023-02
0
4.89
2023-03
0
5.48
2023-04
0
4.68
2023-05
0
4.57
2023-06
0
5.11
2023-07
0
3.84
2023-08
0
3.49
2023-09
0
4.15
2023-10
0
3.44
2023-11
0
4.03
2023-12
0
4.75
2024-01
0
3.71
2024-02
0
4.03
2024-03
0
4.44
2024-04
0
4.69
2024-05
0
2.97
2024-06
0
5.18
2024-07
0
4.29
2024-08
0
4.45
2024-09
0
4.44
2024-10
0
3.38
2024-11
0
4.11
2024-12
0
4.21
2025-01
0
6.01
2025-02
0
4.46
2025-03
0
5.26
2025-04
0
5.89
2025-05
0
4.9
2025-06
0
4.97
2025-07
0
4.26
2025-08
0
4.46
2025-09
0
4.17
2025-10
0
4.34
2025-11
0
4.65
2025-12
0
5.86
2026-01
0
5.23
2026-02
0
4.98
2026-03
0
4.19
2026-04
0
4.32
2026-05
0
4.18
2026-06
0
4.79
This device (reports/month)Average device in GAM (reports/device/month)