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3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
Model OS3CDK15 · ORANGE SURGICAL INSTRUMENTS, LLC · DI B354OS3CDK15
GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500
GEI — Electrosurgical, Cutting & Coagulation & Accessories · Class II · 21 CFR 878.4400
HIF — Insufflator, Laparoscopic · Class II · 21 CFR 884.1730
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
5.26
2019-02
0
4.02
2019-03
0
3.85
2019-04
0
5.08
2019-05
0
3.91
2019-06
0
4.48
2019-07
0
4.59
2019-08
0
4.7
2019-09
0
4.09
2019-10
0
4.86
2019-11
0
4.28
2019-12
0
4.26
2020-01
0
3.98
2020-02
0
4.37
2020-03
0
4.34
2020-04
0
3.23
2020-05
0
3.17
2020-06
0
4.19
2020-07
0
4.98
2020-08
0
4.58
2020-09
0
5.4
2020-10
0
5.07
2020-11
0
5.06
2020-12
0
5
2021-01
0
5.03
2021-02
0
4.68
2021-03
0
5.5
2021-04
0
5.31
2021-05
0
4.86
2021-06
0
5.32
2021-07
0
4.69
2021-08
0
4.39
2021-09
0
4.71
2021-10
0
5.52
2021-11
0
4.96
2021-12
0
5.49
2022-01
0
5.18
2022-02
0
5.34
2022-03
0
5.92
2022-04
0
5.94
2022-05
0
5.96
2022-06
0
6.44
2022-07
0
5.47
2022-08
0
5.42
2022-09
0
5.3
2022-10
0
5.09
2022-11
0
5.11
2022-12
0
4.96
2023-01
0
5.64
2023-02
0
4.78
2023-03
0
5.52
2023-04
0
5.17
2023-05
0
5.47
2023-06
0
5.93
2023-07
0
5.45
2023-08
0
5.34
2023-09
0
5.61
2023-10
0
5.75
2023-11
0
5.14
2023-12
0
5.52
2024-01
0
5.76
2024-02
0
5.85
2024-03
0
5.91
2024-04
0
6.14
2024-05
0
5.92
2024-06
0
6.33
2024-07
0
5.55
2024-08
0
5.88
2024-09
0
5.99
2024-10
0
6.76
2024-11
0
5.14
2024-12
0
4.41
2025-01
0
4.81
2025-02
0
4.3
2025-03
0
5.76
2025-04
0
4.46
2025-05
0
4.86
2025-06
0
4.81
2025-07
0
4.94
2025-08
0
5.49
2025-09
0
4.48
2025-10
0
4.89
2025-11
0
5.26
2025-12
0
5.89
2026-01
0
5.14
2026-02
0
5.54
2026-03
0
6
2026-04
0
5.68
2026-05
0
5.9
2026-06
0
5.29
This device (reports/month)Average device in GCJ, GEI, HIF (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — ORANGE SURGICAL INSTRUMENTS, LLC