Print-ready dossier — use your browser's print dialog to save as PDF.
Genesys HTA Control Unit - Refurbished
Model M00658001R0 · Minerva Surgical, Inc. · DI 00850033976021
MNB — Device, Thermal Ablation, Endometrial · Class III
UDILibrary device dossier · generated 2026-09-11 · 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 (11)
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: 11
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
2.29
2019-02
0
3
2019-03
0
4.43
2019-04
0
3.67
2019-05
0
5.83
2019-06
0
1.75
2019-07
0
4.17
2019-08
0
5
2019-09
0
2.57
2019-10
3
4.22
2019-11
1
4.25
2019-12
0
2.5
2020-01
2
2.78
2020-02
0
3.2
2020-03
0
2.43
2020-04
0
2.17
2020-05
0
3.33
2020-06
0
2.5
2020-07
1
2.71
2020-08
0
3.5
2020-09
0
4.86
2020-10
0
2.83
2020-11
1
3.6
2020-12
0
8
2021-01
0
2.67
2021-02
0
4
2021-03
0
8.2
2021-04
0
6.5
2021-05
0
7.8
2021-06
0
8
2021-07
0
4.83
2021-08
0
8.67
2021-09
0
3.71
2021-10
0
4
2021-11
0
13
2021-12
0
13.75
2022-01
0
4.33
2022-02
0
2.17
2022-03
0
5.83
2022-04
0
2.25
2022-05
0
2.5
2022-06
0
3.43
2022-07
0
5.5
2022-08
0
7.75
2022-09
0
3.4
2022-10
0
5.43
2022-11
3
4.63
2022-12
0
11.2
2023-01
0
5.83
2023-02
0
3.71
2023-03
0
5.57
2023-04
0
7.2
2023-05
0
5.6
2023-06
0
6.17
2023-07
0
5.75
2023-08
0
6
2023-09
0
3.22
2023-10
0
4
2023-11
0
5.44
2023-12
0
7
2024-01
0
4.22
2024-02
0
12.75
2024-03
0
6.17
2024-04
0
3.8
2024-05
0
10.5
2024-06
0
3.71
2024-07
0
2.75
2024-08
0
2.33
2024-09
0
5.67
2024-10
0
3.8
2024-11
0
5.5
2024-12
0
3
2025-01
0
4.56
2025-02
0
4.67
2025-03
0
6.33
2025-04
0
5.14
2025-05
0
7.25
2025-06
0
6.14
2025-07
0
3
2025-08
0
9
2025-09
0
4.17
2025-10
0
4
2025-11
0
3
2025-12
0
5.33
2026-01
0
5.5
2026-02
0
4.4
2026-03
0
11
2026-04
0
4.5
2026-05
0
2.33
2026-06
0
8.5
This device (reports/month)Average device in MNB (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Minerva Surgical, Inc.
NAI 2021-07-14 Minerva Surgical Incorporated · 0 citations
NAI 2021-07-14 Minerva Surgical Incorporated · 0 citations
NAI 2016-08-30 Minerva Surgical Incorporated · 0 citations
NAI 2016-08-30 Minerva Surgical Incorporated · 0 citations
NAI 2015-02-27 Minerva Surgical Incorporated · 0 citations
NAI 2015-02-27 Minerva Surgical Incorporated · 0 citations
NAI 2014-11-07 Minerva Surgical Incorporated · 0 citations
NAI 2014-11-07 Minerva Surgical Incorporated · 0 citations