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Control Unit

Model E-1301 · DEX SURGICAL · DI 03665772000008

GEI — Electrosurgical, Cutting & Coagulation & Accessories · Class II · 21 CFR 878.4400

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	6.86
2019-02	0	4.35
2019-03	0	4.42
2019-04	0	6.12
2019-05	0	4.8
2019-06	0	5.04
2019-07	0	5.86
2019-08	0	6.1
2019-09	0	4.99
2019-10	0	5.85
2019-11	0	5.62
2019-12	0	5.41
2020-01	0	4.81
2020-02	0	5.57
2020-03	0	5.68
2020-04	0	3.57
2020-05	0	3.76
2020-06	0	5.14
2020-07	0	6.56
2020-08	0	4.64
2020-09	0	5.86
2020-10	0	5.55
2020-11	0	5.14
2020-12	0	5.31
2021-01	0	5.17
2021-02	0	4.89
2021-03	0	5.7
2021-04	0	5.26
2021-05	0	5.14
2021-06	0	5.83
2021-07	0	4.89
2021-08	0	4.3
2021-09	0	4.77
2021-10	0	6.17
2021-11	0	5.57
2021-12	0	5.56
2022-01	0	5.04
2022-02	0	5.15
2022-03	0	5.75
2022-04	0	4.98
2022-05	0	5.78
2022-06	0	6.3
2022-07	0	4.36
2022-08	0	4.59
2022-09	0	5
2022-10	0	4.76
2022-11	0	4.61
2022-12	0	4.04
2023-01	0	5.52
2023-02	0	4.59
2023-03	0	4.87
2023-04	0	4.78
2023-05	0	5.14
2023-06	0	4.78
2023-07	0	4.82
2023-08	0	4.44
2023-09	0	5.23
2023-10	0	5.1
2023-11	0	4.38
2023-12	0	4.79
2024-01	0	5.54
2024-02	0	5.46
2024-03	0	6.16
2024-04	0	6.04
2024-05	0	6.28
2024-06	0	5.39
2024-07	0	5.05
2024-08	0	5.01
2024-09	0	5.19
2024-10	0	5.7
2024-11	0	5.29
2024-12	0	4.06
2025-01	0	5.17
2025-02	0	4.46
2025-03	0	6.28
2025-04	0	4.39
2025-05	0	5.16
2025-06	0	5.08
2025-07	0	5.2
2025-08	0	5.45
2025-09	0	4.85
2025-10	0	5.14
2025-11	0	5.55
2025-12	0	5.81
2026-01	0	5.63
2026-02	0	5.98
2026-03	0	6.2
2026-04	0	5.43
2026-05	0	6.19
2026-06	0	5.56

This device (reports/month)Average device in GEI (reports/device/month)

Regulatory clearances

K191878 SESE 2021-01-29 (k number procode)

Predicate lineage

K191878 — cites (transitively): K061425 (d1), K173919 (d1), K123102 (d2), K131861 (d2), K170875 (d2), K982623 (d3), K090993 (d3), K122532 (d3), K130726 (d3), K141075 (d3), K152448 (d3)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — DEX SURGICAL

Nothing in the loaded window.