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Gelseal™
Model 434024/8 · VASCUTEK LTD · DI 05037881100593
DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · Class II · 21 CFR 870.3450
MAL — Graft, Vascular, Synthetic/Biologic Composite · Class II · 21 CFR 870.3450
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 (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
2.5
2019-02
0
3.14
2019-03
0
2.58
2019-04
0
2.78
2019-05
0
2.2
2019-06
0
2.13
2019-07
0
2.12
2019-08
0
5.89
2019-09
0
2.58
2019-10
0
4.04
2019-11
0
3.5
2019-12
0
3.25
2020-01
0
2.67
2020-02
0
2.38
2020-03
0
3.43
2020-04
0
2.88
2020-05
0
4.29
2020-06
0
3
2020-07
0
4
2020-08
0
2.22
2020-09
0
2.25
2020-10
0
2.67
2020-11
0
2.69
2020-12
0
2.54
2021-01
0
2.09
2021-02
0
2.67
2021-03
0
2.13
2021-04
0
2.46
2021-05
0
3.73
2021-06
0
3.14
2021-07
0
3.67
2021-08
0
2
2021-09
0
3
2021-10
0
2.83
2021-11
0
2.22
2021-12
0
3.1
2022-01
0
2.71
2022-02
0
2.83
2022-03
0
4.22
2022-04
0
2.7
2022-05
0
3.2
2022-06
0
4.38
2022-07
0
1.88
2022-08
0
2.86
2022-09
0
2.63
2022-10
0
3.33
2022-11
0
4
2022-12
0
4
2023-01
0
2.33
2023-02
0
3.25
2023-03
0
4.8
2023-04
0
3.71
2023-05
0
3.29
2023-06
0
3.33
2023-07
0
4.36
2023-08
0
2.79
2023-09
0
2.88
2023-10
0
2.25
2023-11
0
3
2023-12
0
3
2024-01
0
5
2024-02
0
4.43
2024-03
0
2.38
2024-04
0
2
2024-05
0
2.71
2024-06
0
3.8
2024-07
0
2.55
2024-08
0
1.83
2024-09
0
1.5
2024-10
0
2.2
2024-11
0
1.5
2024-12
0
2.14
2025-01
0
2.36
2025-02
0
1
2025-03
0
2
2025-04
0
3.17
2025-05
0
3.63
2025-06
0
1.9
2025-07
0
4.88
2025-08
0
1.83
2025-09
0
3
2025-10
0
3
2025-11
0
2.75
2025-12
0
2.67
2026-01
0
1.83
2026-02
0
1.83
2026-03
0
3.33
2026-04
0
6.9
2026-05
0
3.58
2026-06
0
4.5
This device (reports/month)Average device in DSY, MAL (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K162803 — cites (transitively): K955230 (d1), K990503 (d1), P890045 (d1) — cited as predicate by K241070
Lineage extracted from public 510(k) summary text (heuristic).