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0.8mm S2 Mini Carbide Round Bur
Model 1502170 · Bien-Air Surgery SA · DI 17630055504866
EQJ — Bur, Ear, Nose And Throat · Class I · 21 CFR 874.4140
ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece · Class II · 21 CFR 874.4250
NLY — Microdebrider, Ent, High Speed, Single Use, Reprocessed · Class I · 21 CFR 874.4140
UDILibrary device dossier · generated 2026-09-06 · 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
3.87
2019-02
0
3.38
2019-03
0
5.78
2019-04
0
5.05
2019-05
0
3.56
2019-06
0
3.96
2019-07
0
3.91
2019-08
0
5.01
2019-09
0
3.89
2019-10
0
4.01
2019-11
0
4.99
2019-12
0
4.64
2020-01
0
3.89
2020-02
0
3.75
2020-03
0
4.45
2020-04
0
4.51
2020-05
0
2.98
2020-06
0
5.46
2020-07
0
5.01
2020-08
0
4.46
2020-09
0
4.15
2020-10
0
5.14
2020-11
0
4.76
2020-12
0
4.72
2021-01
0
4.7
2021-02
0
5.06
2021-03
0
5.38
2021-04
0
4.44
2021-05
0
4.13
2021-06
0
5.05
2021-07
0
4.21
2021-08
0
4.77
2021-09
0
3.6
2021-10
0
3.03
2021-11
0
3.95
2021-12
0
3.54
2022-01
0
3.43
2022-02
0
2.95
2022-03
0
3.21
2022-04
0
3.58
2022-05
0
2.86
2022-06
0
3.89
2022-07
0
3.78
2022-08
0
3.83
2022-09
0
3.33
2022-10
0
3.69
2022-11
0
3.91
2022-12
0
3.8
2023-01
0
3.15
2023-02
0
3.67
2023-03
0
4.27
2023-04
0
3.55
2023-05
0
4.77
2023-06
0
3.59
2023-07
0
3.97
2023-08
0
3.48
2023-09
0
3.49
2023-10
0
3.49
2023-11
0
3.44
2023-12
0
3.02
2024-01
0
3.72
2024-02
0
4.33
2024-03
0
3.71
2024-04
0
3.52
2024-05
0
2.92
2024-06
0
3.12
2024-07
0
3.28
2024-08
0
3.45
2024-09
0
4.27
2024-10
0
3.61
2024-11
0
3.34
2024-12
0
3.21
2025-01
0
3.25
2025-02
0
6.21
2025-03
0
4.35
2025-04
0
2.78
2025-05
0
3.95
2025-06
0
3.14
2025-07
0
3.43
2025-08
0
3.52
2025-09
0
3.05
2025-10
0
3.31
2025-11
0
3.16
2025-12
0
3.33
2026-01
0
2.46
2026-02
0
3.06
2026-03
0
3.38
2026-04
0
4.64
2026-05
0
3.49
2026-06
0
3.6
This device (reports/month)Average device in EQJ, ERL, NLY (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Bien-Air Surgery SA