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Clearify
Model 21-345 · Covidien LP · DI 10884521213562
GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-15 · 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 (163)
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.
Malfunction: 159 · Injury: 4
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
2.42
2019-02
4
3.53
2019-03
0
2.95
2019-04
1
3.13
2019-05
1
2.46
2019-06
4
3.58
2019-07
0
2.42
2019-08
0
2.47
2019-09
3
2.47
2019-10
1
2.71
2019-11
2
2.12
2019-12
5
2.35
2020-01
2
2.55
2020-02
8
2.7
2020-03
1
2.28
2020-04
1
2.54
2020-05
0
1.98
2020-06
1
2.78
2020-07
1
2.77
2020-08
1
4.33
2020-09
1
4.4
2020-10
5
3.99
2020-11
2
4.47
2020-12
1
3.87
2021-01
0
3.99
2021-02
0
3.89
2021-03
3
4.83
2021-04
1
4.7
2021-05
2
4.05
2021-06
2
4.28
2021-07
3
3.88
2021-08
1
3.87
2021-09
0
3.91
2021-10
1
3.99
2021-11
1
3.49
2021-12
1
4.46
2022-01
2
4.57
2022-02
1
5.03
2022-03
2
5.45
2022-04
1
6.48
2022-05
1
5.46
2022-06
0
6.07
2022-07
0
6.34
2022-08
2
6.38
2022-09
0
5.53
2022-10
1
5.35
2022-11
2
5.52
2022-12
3
6
2023-01
2
5.73
2023-02
2
4.87
2023-03
1
5.86
2023-04
0
5.47
2023-05
2
5.86
2023-06
0
7.1
2023-07
0
6.1
2023-08
0
6.28
2023-09
0
5.92
2023-10
4
6.38
2023-11
2
5.76
2023-12
2
6.05
2024-01
15
5.53
2024-02
3
6.18
2024-03
1
5.56
2024-04
2
6.32
2024-05
0
5.3
2024-06
0
7.07
2024-07
1
5.75
2024-08
3
6.5
2024-09
0
6.28
2024-10
0
7.11
2024-11
4
4.55
2024-12
0
4.77
2025-01
4
4.42
2025-02
0
4.03
2025-03
1
5.17
2025-04
8
4.67
2025-05
0
4.69
2025-06
8
4.58
2025-07
3
4.68
2025-08
2
5.45
2025-09
0
3.97
2025-10
2
4.59
2025-11
2
4.86
2025-12
0
6.15
2026-01
5
4.95
2026-02
1
5.05
2026-03
0
5.77
2026-04
4
6.2
2026-05
0
5.86
2026-06
4
5.01
This device (reports/month)Average device in GCJ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K062779 — cited as predicate by K150569, K163257, K182080, K200228, K221533
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Covidien LP
Warning Letter 2012-06-14 Covidien, LP
Warning Letter 2012-06-14 Covidien, LP
Warning Letter 2011-10-04 Oridion Medical 1987 Ltd.