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10mm Dilator
Model SR10-6016 · Surgentec, LLC · DI 00858406007266
FMF — Syringe, Piston · Class II · 21 CFR 880.5860
HTR — Rasp · Class I · 21 CFR 878.4800
UDILibrary device dossier · generated 2026-09-07 · 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
2.88
2019-02
0
3.83
2019-03
0
3.37
2019-04
0
3.19
2019-05
0
4
2019-06
0
3.2
2019-07
0
3.55
2019-08
0
4.08
2019-09
0
4.22
2019-10
0
3.42
2019-11
0
3.02
2019-12
0
2.8
2020-01
0
3.15
2020-02
0
3.53
2020-03
0
2.95
2020-04
0
3.45
2020-05
0
3.28
2020-06
0
2.62
2020-07
0
3.24
2020-08
0
3.24
2020-09
0
4.05
2020-10
0
3.82
2020-11
0
3.28
2020-12
0
3.2
2021-01
0
2.4
2021-02
0
3.32
2021-03
0
2.96
2021-04
0
3.02
2021-05
0
2.16
2021-06
0
2.31
2021-07
0
3.09
2021-08
0
3.13
2021-09
0
3.43
2021-10
0
2.55
2021-11
0
2.37
2021-12
0
2.31
2022-01
0
2.24
2022-02
0
2.81
2022-03
0
2.58
2022-04
0
2.3
2022-05
0
2.42
2022-06
0
2.62
2022-07
0
2.56
2022-08
0
2.65
2022-09
0
2.55
2022-10
0
2.68
2022-11
0
4.2
2022-12
0
3.16
2023-01
0
4.24
2023-02
0
4.73
2023-03
0
5.6
2023-04
0
4.88
2023-05
0
5
2023-06
0
5.14
2023-07
0
6.02
2023-08
0
5.7
2023-09
0
4.83
2023-10
0
4.48
2023-11
0
3.79
2023-12
0
5.51
2024-01
0
4.2
2024-02
0
7.28
2024-03
0
8.55
2024-04
0
13.36
2024-05
0
17.87
2024-06
0
16.36
2024-07
0
13.58
2024-08
0
9.31
2024-09
0
7.24
2024-10
0
5.38
2024-11
0
3.94
2024-12
0
4.21
2025-01
0
2.91
2025-02
0
2.37
2025-03
0
2.97
2025-04
0
3.33
2025-05
0
2.84
2025-06
0
4.16
2025-07
0
2.9
2025-08
0
2.81
2025-09
0
2.66
2025-10
0
3.28
2025-11
0
3.18
2025-12
0
2.47
2026-01
0
2.95
2026-02
0
3.7
2026-03
0
2.95
2026-04
0
2.86
2026-05
0
2.87
2026-06
0
3.54
This device (reports/month)Average device in FMF, HTR (reports/device/month)