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Aveta Auto 5 Fr Disposable Resecting Device
Model 215-2023 · MEDITRINA, INC. · DI 00850006759668
FAJ — Cystoscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500
HIG — Insufflator, Hysteroscopic · Class II · 21 CFR 884.1700
HIH — Hysteroscope (And Accessories) · Class II · 21 CFR 884.1690
UDILibrary device dossier · generated 2026-09-12 · 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
3.78
2019-02
0
2.64
2019-03
0
3.13
2019-04
0
4.36
2019-05
0
2.21
2019-06
0
4.77
2019-07
0
4.32
2019-08
0
3
2019-09
0
2.75
2019-10
0
3.05
2019-11
0
2.72
2019-12
0
3.52
2020-01
0
3
2020-02
0
3.5
2020-03
0
3.65
2020-04
0
3.07
2020-05
0
2.3
2020-06
0
4.15
2020-07
0
2.08
2020-08
0
2.33
2020-09
0
2.26
2020-10
0
3.08
2020-11
0
2.8
2020-12
0
4.56
2021-01
0
2.85
2021-02
0
6.3
2021-03
0
3.96
2021-04
0
3.08
2021-05
0
2.65
2021-06
0
6.65
2021-07
0
8.57
2021-08
0
4.76
2021-09
0
4.91
2021-10
0
6.32
2021-11
0
5
2021-12
0
6.1
2022-01
0
5.14
2022-02
0
3.27
2022-03
0
8.13
2022-04
0
3.87
2022-05
0
4.2
2022-06
0
2.31
2022-07
0
3.65
2022-08
0
2.92
2022-09
0
3.24
2022-10
0
3.33
2022-11
0
3.52
2022-12
0
8.64
2023-01
0
15.64
2023-02
0
7.11
2023-03
0
8.98
2023-04
0
10.92
2023-05
0
12.69
2023-06
0
12.69
2023-07
0
8.98
2023-08
0
8.13
2023-09
0
7.48
2023-10
0
8.83
2023-11
0
7.4
2023-12
0
9.78
2024-01
0
7.88
2024-02
0
10.08
2024-03
0
10.56
2024-04
0
8.46
2024-05
0
8.61
2024-06
0
7.73
2024-07
0
8.33
2024-08
0
9.09
2024-09
0
9.91
2024-10
0
8.52
2024-11
0
6.59
2024-12
0
10.38
2025-01
0
7.84
2025-02
0
10.05
2025-03
0
7.74
2025-04
0
8.56
2025-05
0
7.7
2025-06
0
7.2
2025-07
0
7.75
2025-08
0
8.8
2025-09
0
8.37
2025-10
0
14.8
2025-11
0
10.41
2025-12
0
8.38
2026-01
0
11.55
2026-02
0
14.67
2026-03
0
7.22
2026-04
0
10.7
2026-05
0
7.56
2026-06
0
9
This device (reports/month)Average device in FAJ, HIG, HIH (reports/device/month)