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Myosure XL for Fluent Device
Model 50-601XL · Hologic, Inc. · DI 15420045507654
HIH — Hysteroscope (And Accessories) · Class II · 21 CFR 884.1690
UDILibrary device dossier · generated 2026-09-16 · 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 (181)
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: 124 · Malfunction: 53 · Death: 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
4
2019-02
0
2.58
2019-03
0
3.29
2019-04
0
4
2019-05
0
2.2
2019-06
0
5
2019-07
0
4.59
2019-08
0
3.42
2019-09
0
2.33
2019-10
0
3.5
2019-11
0
2.93
2019-12
0
4.27
2020-01
0
3.67
2020-02
0
4
2020-03
2
3.88
2020-04
0
3.27
2020-05
0
2.71
2020-06
0
5
2020-07
0
2.05
2020-08
0
2.67
2020-09
0
2.62
2020-10
0
4
2020-11
0
3.31
2020-12
0
4.33
2021-01
0
2.25
2021-02
8
4.14
2021-03
0
3.44
2021-04
0
3.8
2021-05
0
2.69
2021-06
0
6.18
2021-07
0
8
2021-08
0
4.26
2021-09
0
4.29
2021-10
0
5.75
2021-11
0
4.21
2021-12
2
5.58
2022-01
3
4.76
2022-02
0
3.06
2022-03
1
6.19
2022-04
3
4.15
2022-05
0
5
2022-06
5
2.13
2022-07
0
3.87
2022-08
3
3.42
2022-09
2
3.15
2022-10
9
3
2022-11
5
3.89
2022-12
2
11.2
2023-01
0
20.62
2023-02
6
9.35
2023-03
6
12.22
2023-04
11
13.21
2023-05
10
18.4
2023-06
3
18.95
2023-07
3
11.93
2023-08
0
11.5
2023-09
5
10.06
2023-10
0
10.82
2023-11
0
9.45
2023-12
0
11.69
2024-01
0
9.13
2024-02
0
11.61
2024-03
7
12.31
2024-04
0
10.69
2024-05
1
12.26
2024-06
3
9.57
2024-07
6
10.33
2024-08
4
11.61
2024-09
0
13.31
2024-10
0
10.49
2024-11
4
8.09
2024-12
10
12.53
2025-01
0
11.32
2025-02
0
12.94
2025-03
4
9.6
2025-04
0
10.36
2025-05
0
9.76
2025-06
0
9.05
2025-07
7
9.3
2025-08
4
9.82
2025-09
0
9.47
2025-10
2
8.89
2025-11
0
9.82
2025-12
0
9.93
2026-01
0
12.47
2026-02
12
17.64
2026-03
8
8.42
2026-04
12
8.76
2026-05
0
6.15
2026-06
8
8.38
This device (reports/month)Average device in HIH (reports/device/month)
Regulatory clearances
K181974 SESE 2018-08-23 (k number procode)
Predicate lineage
K181974 — cites (transitively): K172566 (d1), K152723 (d2), K142029 (d3), K132015 (d4) — cited as predicate by K201756
Lineage extracted from public 510(k) summary text (heuristic).
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