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NovaSure SureSound
Model 2007 · Hologic, Inc. · DI 15420045501133
MNB — Device, Thermal Ablation, Endometrial · Class III
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 (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2014-01-24
Z-1094-2014
Class II
Terminated
NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,
k number procode
Adverse-event reports — MAUDE (104)
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.
Injury: 80 · Malfunction: 24
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
1
2.29
2019-02
0
3
2019-03
2
4.43
2019-04
0
3.67
2019-05
0
5.83
2019-06
0
1.75
2019-07
0
4.17
2019-08
1
5
2019-09
1
2.57
2019-10
0
4.22
2019-11
0
4.25
2019-12
0
2.5
2020-01
2
2.78
2020-02
0
3.2
2020-03
1
2.43
2020-04
1
2.17
2020-05
0
3.33
2020-06
0
2.5
2020-07
0
2.71
2020-08
1
3.5
2020-09
2
4.86
2020-10
0
2.83
2020-11
1
3.6
2020-12
0
8
2021-01
1
2.67
2021-02
0
4
2021-03
16
8.2
2021-04
0
6.5
2021-05
5
7.8
2021-06
4
8
2021-07
4
4.83
2021-08
3
8.67
2021-09
2
3.71
2021-10
2
4
2021-11
3
13
2021-12
0
13.75
2022-01
2
4.33
2022-02
4
2.17
2022-03
14
5.83
2022-04
0
2.25
2022-05
0
2.5
2022-06
3
3.43
2022-07
0
5.5
2022-08
7
7.75
2022-09
4
3.4
2022-10
4
5.43
2022-11
4
4.63
2022-12
2
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
1
3.22
2023-10
0
4
2023-11
0
5.44
2023-12
0
7
2024-01
2
4.22
2024-02
0
12.75
2024-03
1
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
3
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
P010013 OK30 2025-12-17 (k number procode)
P010013 OK30 2024-09-06 (k number procode)
P010013 OK30 2024-07-23 (k number procode)
P010013 OK30 2023-10-27 (k number procode)
P010013 OK30 2023-09-22 (k number procode)
P010013 APPR 2022-12-01 (k number procode)
P010013 OK30 2022-11-02 (k number procode)
P010013 OK30 2022-08-04 (k number procode)
P010013 APPR 2022-01-04 (k number procode)
P010013 APPR 2021-12-09 (k number procode)
P010013 OK30 2021-11-15 (k number procode)
P010013 OK30 2021-08-30 (k number procode)
P010013 APPR 2021-06-30 (k number procode)
P010013 OK30 2021-03-30 (k number procode)
P010013 OK30 2020-10-27 (k number procode)
P010013 OK30 2020-10-19 (k number procode)
P010013 APPR 2020-03-02 (k number procode)
P010013 OK30 2019-10-01 (k number procode)
P010013 OK30 2019-09-26 (k number procode)
P010013 OK30 2019-03-01 (k number procode)
Manufacturer compliance record — Hologic, Inc.
Warning Letter 2024-12-18 Hologic, Inc
Warning Letter 2024-12-18 Hologic, Inc
OAI 2025-11-04 Hologic, Inc · 3 citations
OAI 2025-11-04 Hologic, Inc · 3 citations
OAI 2024-09-24 Hologic, Inc · 5 citations
OAI 2024-09-24 Hologic, Inc · 5 citations
VAI 2024-09-12 Hologic Surgical Products Costa Rica, S.R.L. · 0 citations