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20GA Aspirating Laser Probe, SMA905
Model GA-0040000 · Peregrine Surgical, Llc · DI 00632307002137
HQE — Instrument, Vitreous Aspiration And Cutting, Ac-Powered · Class II · 21 CFR 886.4150
HQF — Laser, Ophthalmic · Class II · 21 CFR 886.4390
UDILibrary device dossier · generated 2026-09-13 · 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)
2019-02
0
6.33
2019-03
0
1.67
2019-04
0
1.29
2019-05
0
1.67
2019-06
0
3
2019-07
0
1.67
2019-08
0
2
2019-09
0
1.5
2019-10
0
2.8
2019-11
0
2
2019-12
0
3.75
2020-01
0
2
2020-02
0
3
2020-03
0
2.33
2020-04
0
3.5
2020-05
0
1
2020-06
0
2
2020-07
0
1.5
2020-08
0
1.5
2020-09
0
3.17
2020-10
0
2.17
2020-11
0
6
2020-12
0
2.67
2021-01
0
2.33
2021-02
0
4
2021-03
0
5.4
2021-04
0
3.61
2021-05
0
5.43
2021-06
0
6.5
2021-07
0
7.1
2021-08
0
8.25
2021-09
0
7.2
2021-10
0
5.27
2021-11
0
4.64
2021-12
0
5.53
2022-01
0
4.3
2022-02
0
6.64
2022-03
0
10.9
2022-04
0
5.73
2022-05
0
6.85
2022-06
0
5.31
2022-07
0
5.19
2022-08
0
4.95
2022-09
0
6.25
2022-10
0
5.71
2022-11
0
6.5
2022-12
0
6.92
2023-01
0
4.5
2023-02
0
3.38
2023-03
0
5.2
2023-04
0
5.55
2023-05
0
5.4
2023-06
0
4.58
2023-07
0
5
2023-08
0
3.25
2023-09
0
4.63
2023-10
0
5.15
2023-11
0
3.69
2023-12
0
2.55
2024-01
0
6.27
2024-02
0
4.33
2024-03
0
4.67
2024-04
0
4.56
2024-05
0
4.26
2024-06
0
4.43
2024-07
0
3
2024-08
0
5.1
2024-09
0
4.33
2024-10
0
4.36
2024-11
0
3.94
2024-12
0
3.29
2025-01
0
3.35
2025-02
0
2.95
2025-03
0
3.07
2025-04
0
4.06
2025-05
0
3.35
2025-06
0
2.1
2025-07
0
3.15
2025-08
0
4.06
2025-09
0
4.33
2025-10
0
3.39
2025-11
0
3.67
2025-12
0
3.31
2026-01
0
3.47
2026-02
0
3.65
2026-03
0
3.71
2026-04
0
6.09
2026-05
0
3.8
2026-06
0
4.29
This device (reports/month)Average device in HQE, HQF (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Peregrine Surgical, Llc
Warning Letter 2010-12-20 Peregrine Surgical Ltd
Warning Letter 2010-12-20 Peregrine Surgical Ltd
NAI 2018-09-26 Peregrine Surgical Ltd · 0 citations
NAI 2018-09-26 Peregrine Surgical Ltd · 0 citations
VAI 2015-06-19 Peregrine Surgical Ltd · 0 citations
VAI 2015-06-19 Peregrine Surgical Ltd · 0 citations
VAI 2013-02-07 Peregrine Surgical Ltd · 1 citations
VAI 2013-02-07 Peregrine Surgical Ltd · 1 citations
VAI 2011-06-30 Peregrine Surgical Ltd · 0 citations
VAI 2011-06-30 Peregrine Surgical Ltd · 0 citations